Product Code: HIH FDA class 2 21 CFR 884.1690

Hysteroscope (And Accessories)

Obstetrics/Gynecology

The Hysteroscope (and accessories) is an endoscopic instrument introduced through the cervix into the uterine cavity to allow direct visualization of the endometrium and uterine structures, used for diagnostic evaluation and operative procedures such as polypectomy, myomectomy, or endometrial ablation. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is HIH, regulated under 21 CFR 884.1690, within the Obstetrics/Gynecology specialty. It is eligible for third-party 510(k) review.

View on FDA

510(k)s

171

FEI Numbers

135

Registration Numbers

135

Unique Applicants

Years Active

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Basic Information

Product Code: HIH
Device Class: FDA class 2
Regulation Number: 884.1690
Medical Specialty: Obstetrics/Gynecology
Review Panel: OB
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 171 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253020	Strauss Surgical Resection Instruments	Jun 04, 2026	Substantially Equivalent	American Medical Endoscopy, Inc.
K254050	Manual Tissue Removal Device	May 15, 2026	Substantially Equivalent	Suzhou AcuVu Medical Technology Co., Ltd.
K254251	InnovexView (GC146-17, GC150-20, GC155-23)	Feb 26, 2026	Substantially Equivalent	Shanghai AnQing Medical Instrument Co., Ltd.
K252793	ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope (SH-01A, SH-02A, SH-03A, SH-04A, SH-05A, SH-01B, SH-02B, SH-03B, SH-04B, SH-01C, SH-02C, SH-03C, SH-04C)	Dec 18, 2025	Substantially Equivalent	Jiangsu Jiyuan Medical Technology Co., Ltd.
K252012	SPY Cystoscope/Hysteroscope	Jul 18, 2025	Substantially Equivalent	Stryker Endoscopy
K243382	RZ Resectoscope System	Jun 03, 2025	Substantially Equivalent	Rz Medizintechnik GmbH
K240978	SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G)	Aug 16, 2024	Substantially Equivalent	MacroLux Medical Technology Co., Ltd.
K241987	Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)	Aug 02, 2024	Substantially Equivalent	Guangzhou Red Pine Medical Instrument Co., Ltd.
K240401	ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US)	Jul 26, 2024	Substantially Equivalent	Origyn Medical Technology (Hangzhou) Co., Ltd.
K231260	HTx Disposable Hysteroscope System	Mar 05, 2024	Substantially Equivalent	Suzhou AcuVu Medical Technology Co., Ltd.
K233635	SPY Cystoscope/Hysteroscope	Feb 12, 2024	Substantially Equivalent	Stryker Endoscopy
K232003	Endoscopic Video Image Processor, Single-Use Video Hysteroscope	Feb 12, 2024	Substantially Equivalent	Guangzhou Red Pine Medical Instrument Co., Ltd.
K233500	Benesta Tissue Removal Device	Nov 30, 2023	Substantially Equivalent	Caldera Medical, Inc.
K223885	HOPKINS Telescopes	Sep 14, 2023	Substantially Equivalent	Karl Storz Endoscopy America, Inc.
K223813	Aveta System 2.0	Aug 21, 2023	Substantially Equivalent	Meditrina, Inc.
K223520	UNIDRIVE SIII System	Apr 27, 2023	Substantially Equivalent	Karl Storz-Endoscopy-America, Inc.
K221557	Visera Hysterovideoscope Olympus HYF Type V	Sep 02, 2022	Substantially Equivalent	Olympus Medical Systems Corporation
K213171	Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral)	May 26, 2022	Substantially Equivalent	Meditrina, Inc.
K213207	Sheath, Stopcock Accessory	Dec 22, 2021	Substantially Equivalent	Olympus Winter & Ibe GmbH
K202445	Hystero-V Hysteroscope	Nov 23, 2021	Substantially Equivalent	Hysterovue, Inc.
K210270	Medical Endoscope Image Processing System	Oct 01, 2021	Substantially Equivalent	Jiangsu Jiyuan Medical Technology Co., Ltd.
K211227	HTx Disposable Hysteroscope System	Sep 15, 2021	Substantially Equivalent	Acuvu, Inc.
K192811	BenestaTM Tissue Removal Device	Oct 23, 2020	Substantially Equivalent	Caldera Medical, Inc.
K201970	Schoelly Cystoscopes/Hysteroscopes and Accessories	Oct 08, 2020	Substantially Equivalent	Schoelly Fiberoptic GmbH
K201756	Reprocessed MyoSure Tissue Removal Device, Reprocessed MyoSure REACH Tissue Removal Device, Reprocessed MyoSure LITE Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device for Fluent	Sep 25, 2020	Substantially Equivalent	Stryker Sustainability Solutions
K192822	Benesta Hysteroscope	Sep 09, 2020	Substantially Equivalent	Caldera Medical, Inc.
K200038	Endosee System	Feb 05, 2020	Substantially Equivalent	CooperSurgical, Inc.
K193007	LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module	Jan 17, 2020	Substantially Equivalent	Lina Medical Aps
K191538	Resectr Tissue Resection Device	Jan 16, 2020	Substantially Equivalent	Boston Scientific Corporation
K192100	Aveta Disposable Hysteroscope	Dec 19, 2019	Substantially Equivalent	Meditrina, Inc.
K190797	Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01)	Nov 18, 2019	Substantially Equivalent	Reed Medical (Zhejiang) Co., Ltd.
K192278	Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic)	Nov 01, 2019	Substantially Equivalent	Uvision360, Inc.
K191958	Aveta System	Oct 01, 2019	Substantially Equivalent	Meditrina, Inc.
K191281	Omni Hysteroscope, Omni Lok cervical seal	Aug 29, 2019	Substantially Equivalent	Hologic, Inc.
K191335	Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags	Jun 06, 2019	Substantially Equivalent	Corinth Medtech, Inc.
K190827	Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid	Jun 06, 2019	Substantially Equivalent	Uvision360, Inc.
K182975	MAKO 7	May 21, 2019	Substantially Equivalent	Boston Scientific Corporation
K190372	Aveta System	May 16, 2019	Substantially Equivalent	Meditrina, Inc.
K190639	Endosee System	May 15, 2019	Substantially Equivalent	CooperSurgical, Inc.
K181545	Hysteroscope System	May 10, 2019	Substantially Equivalent	Shanghai AnQing Medical Instrument Co., Ltd.
K190113	Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags	Apr 24, 2019	Substantially Equivalent	Corinth Medtech, Inc.
K183020	Endosee System	Jan 31, 2019	Substantially Equivalent	CooperSurgical, Inc.
K182675	Polygon Resection Device	Jan 04, 2019	Substantially Equivalent	Polygon Medical, Inc.
K182006	Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths	Dec 06, 2018	Substantially Equivalent	Hologic, Inc.
K180496	TruClear Elite Hysteroscope	Aug 29, 2018	Substantially Equivalent	Covidien
K181974	MyoSure XL Tissue Removal Device for Fluent	Aug 23, 2018	Substantially Equivalent	Hologic, Inc.
K180752	Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set, Veloxion Saline Pole	Jul 25, 2018	Substantially Equivalent	Corinth Medtech, Inc.
K173070	HSW Resection Instruments	Jun 08, 2018	Substantially Equivalent	Henke-Sass, Wolf GmbH
K173901	MyoSure MANUAL Tissue Removal Device	May 08, 2018	Substantially Equivalent	Hologic, Inc.
K180096	GDT-1000 System	Apr 16, 2018	Substantially Equivalent	Acuvu, Inc.
K171113	LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI cable and on-board LCD-6 units, LiNA OperaScope Recording Module	Jan 04, 2018	Substantially Equivalent	Lina Medical Aps
K172566	Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices	Sep 20, 2017	Substantially Equivalent	Hologic, Inc.
K170660	Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula	Jul 13, 2017	Substantially Equivalent	CooperSurgical, Inc.
K161763	Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device	Nov 22, 2016	Substantially Equivalent	Smith & Nephew, Inc.
K160751	Symphion Endoscope and Symphion Cervical Sheath	Jun 14, 2016	Substantially Equivalent	Boston Scientific
K160510	MAKO 7	Jun 09, 2016	Substantially Equivalent	Nvision Medical Corporation
K152723	Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices	Nov 13, 2015	Substantially Equivalent	Hologic, Inc.
K151275	MAKO Device	Nov 13, 2015	Substantially Equivalent	Nvision Medical
K152143	TRUCLEAR Operative Hysteroscope 5C and Sheath 5C	Sep 02, 2015	Substantially Equivalent	Smith & Nephew, Inc.
K150158	Schoelly Cystoscopes/Hysteroscopes and Accessories	Mar 09, 2015	Substantially Equivalent	Schoelly Fiberoptic GmbH
K141515	AED HYSTEROSCOPE AND ACCESSORIES	Jan 07, 2015	Substantially Equivalent	National Advanced Endoscopy Devices, Inc.
K142029	MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM	Nov 26, 2014	Substantially Equivalent	Hologic, Inc.
K132384	U-SCOPE 8000 SYSTEM WITH HSC+EMB CANNULA	Jul 02, 2014	Substantially Equivalent	Endosec Corporation
K132015	TRUCLEAR MORCELLATION SYSTEM AND TRUCLEAR MORCELLATORS	Dec 13, 2013	Substantially Equivalent	Smith & Nephew, Inc.
K131736	MYOSURE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE TISSUE REMOVAL DEVICE (3 PACK)	Aug 22, 2013	Substantially Equivalent	Hologic, Inc.
K131581	MYOSURE TISSUE REMOVAL DEVICE (1 PACK AND 3 PACK)	Aug 22, 2013	Substantially Equivalent	Hologic, Inc.
K123330	IOGYN ENDOSCOPE	Mar 19, 2013	Substantially Equivalent	Iogyn, Inc.
K123151	ENDOSEE MODEL 8000 U-SCOPE	Mar 08, 2013	Substantially Equivalent	Endosee Corp
K122563	MYOSURE XL ROD LENS HYSTEROSCOPE, MYOSURE XL OUTLFOW CHANNEL	Sep 19, 2012	Substantially Equivalent	Hologic, Inc.
K122498	MYOSURE XL TISSUE REMOVAL DEVICE (1 PACK) MYOSURE XL TISSUE REMOVAL DEVICE (3 PACK)	Sep 10, 2012	Substantially Equivalent	Hologic, Inc.
K121868	MYOSURE LITE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE LITE TISSUE REMOVAL DEVICE (3 PACK)	Jul 19, 2012	Substantially Equivalent	Hologic, Inc.
K120593	MYOSURE CONTROL UNIT	Mar 23, 2012	Substantially Equivalent	Hologic, Inc.
K112134	TRUCLEAR OPERATIVE HYSTEROSCOPE	Nov 22, 2011	Substantially Equivalent	Smith & Nephew, Inc.
K110038	TRUCLEAR MORCELLATOR SYSTEM	Mar 30, 2011	Substantially Equivalent	Smith & Nephew, Inc.
K103389	TRUCLEAR INCISOR PLUS BLADE 2.9	Mar 25, 2011	Substantially Equivalent	Smith & Nephew, Inc.
K102686	MYOSURE ROD LENS SCOPE SEALS	Oct 15, 2010	Substantially Equivalent	Interlace Medical, Inc.
K093218	FEMEYE TWO	May 18, 2010	Substantially Equivalent	Fem Suite, LLC
K100559	MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM	Mar 30, 2010	Substantially Equivalent	Interlace Medical, Inc.
K092421	ALPHAHYSTEROSCOPE, FIBEROPTIC, OPERATIVE AND DIAGNOSTIC	Feb 12, 2010	Substantially Equivalent	Gimmi GmbH
K091838	OBP SELF SEALING ENDOSCOPIC SEAL WITH LUER LOCK	Dec 04, 2009	Substantially Equivalent	Obp Medical
K091100	MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM	Oct 23, 2009	Substantially Equivalent	Interlace Medical, Inc.
K092278	GYRUS ACMI INVISIO DIGITAL HYSTEROSCOPE, MODEL IDH-4	Sep 29, 2009	Substantially Equivalent	Gyrus Acmi, Inc.
K091465	MYOSURE ROD LENS HYSTEROSCOPE	Aug 21, 2009	Substantially Equivalent	Interlace Medical, Inc.
K081070	INTERLACE MEDICAL OPERATIVE HYSTEROSCOPY SYSTEM	Jul 23, 2008	Substantially Equivalent	Interlace Medical, Inc.
K073690	INTERLACE MEDICAL HYSTEROSCOPIC MORCELLATION SYSTEM	Apr 17, 2008	Substantially Equivalent	Interlace Medical, Inc.
K071127	FLEXIBLE HYSTEROSCOPE WITH ENDOSHEATH SYSTEM	Nov 16, 2007	Substantially Equivalent	Vision-Sciences, Inc.
K053583	OPTIVIA HYSTEROSCOPIC INTRODUCER, OPTIVIA STEERABLE WORKING CHANNEL	Mar 31, 2006	Substantially Equivalent	Optivia Medical, LLC
K041774	IUR RECIPROCATING MORCELLATOR MODEL # 7210517	Oct 07, 2004	Substantially Equivalent	Smith & Nephew, Inc.
K040390	STRYKER UROLOGY AND GYNECOLOGY HARDWARE SYSTEM	May 17, 2004	Substantially Equivalent	Stryker Endoscopy
K040302	VERSAPOINT RESECTOSCOPIC SYSTEM	Mar 09, 2004	Substantially Equivalent	Gynecare, A Div. of Ethicon, Inc.
K033113	UNIVERSAL OPERATING HYSTERISCOPE SET BY SOLIMA-ZUPI, CONSISTING OF OPTIC, INNER AND OUTER SHEATHS, FORCEPS, MODEL 8753	Dec 23, 2003	Substantially Equivalent	Richard Wolf Medical Instruments Corp.
K031787	SMITH & NEPHEW IUR MORCELLATION SYSTEM	Dec 02, 2003	Substantially Equivalent	Smith & Nephew, Inc.
K031974	ASAP HYSTEROSCOPE AND GYNECOLOGIC LAPAROSCOPE (SURGERY) 10-00018-00, 10-0019-00, 100020-00, 10-0021-00, 10-0022-00, 10-0	Sep 29, 2003	Substantially Equivalent	Asap Endoscopic Products GmbH
K022445	VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V	Jan 24, 2003	Substantially Equivalent	Olympus Optical Co., Ltd.
K022480	ACMI DISPOSABLE BIPOLAR CORD, MODEL DBC	Aug 22, 2002	Substantially Equivalent	Acmi Corporation
K012869	GIMMI ALPHA HYSTEROSCOPES & ACCESSORIES, MODELS E.8XXX.XX, T.8XXX.XX, ZXXX.XX,S.XXXX.XX, K0142.25	Mar 11, 2002	Substantially Equivalent	Gimmi GmbH
K013870	SMITH & NEPHEW OPERATIVE HYSTEROSCOPE, MODEL 7209208; SMITH & NEPHEW CONTINUOUS FLOW SHEATH, MODEL 8105224	Jan 17, 2002	Substantially Equivalent	Smith & Nephew, Inc.
K003802	HYSTEROSCOPES	Jul 22, 2001	Substantially Equivalent	Global Endoscopy, Inc.
K001740	KSEA MONOPOLAR VAPORIZATION ELECTRODES	Aug 22, 2000	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K000673	HYSTEROSCOPE OPERATING SHEATH AND INSERT, MODEL 8988.031/.041/.231/.241	May 26, 2000	Substantially Equivalent	Richard Wolf Medical Instruments Corp.
K994418	VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA)	Jan 24, 2000	Substantially Equivalent	ETHICON, Inc.
K992901	GYNECARE VERSAPOINT G-VAP ELECTRODE	Jan 18, 2000	Substantially Equivalent	Gynecare, Inc.
K993749	GYRUS HYSTEROSCOPIC RESECTOSCOPE	Dec 03, 1999	Substantially Equivalent	Gyrus Medical , Ltd.
K991563	CONTINUOUS FLOW HYSTERO-RESECTOSCOPE, KNIFE ELECTRODE, SPIKE ELECTRODE, VAPORISATION ELECTRODE, COAGULATION ELECTRODE, C	Oct 13, 1999	Substantially Equivalent	Henke Sass Wolf of America, Inc.
K992027	KONINCKX UTERINE MANIPULATOR, KECKSTEIN-SCHIFF UTERINE MANIPULATOR, CLERMONT UTERINE MANIPULATOR	Sep 09, 1999	Substantially Equivalent	Karl Storz Endoscopy
K990910	MTP HAMOU ENDOMAT DISPOSABLE TUBING SETS	Jun 03, 1999	Substantially Equivalent	Mtp Medical Technical Promotion GmbH
K990411	MVM 7.5 FRENCH FLEXIBLE HYSTEROSCOPE	May 11, 1999	Substantially Equivalent	Karl Storz Endoscopy
K982738	VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA)	Mar 01, 1999	Substantially Equivalent	Gynecare, Inc.
K983901	KSEA HF-SNARE	Feb 01, 1999	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K982771	GYRUS HYSTEROSCOPIC RESECTOSCOPE	Jan 21, 1999	Substantially Equivalent	Gyrus Medical , Ltd.
K983569	KSEA MONOPOLAR VAPORIZATION ELECTRODES	Jan 08, 1999	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K982659	MEDIVISION HYSTEROSCOPE	Oct 07, 1998	Substantially Equivalent	Medivision Scope Service Center, Inc.
K980302	WORKING ELEMENTS, RESECTOSCOPE SHEATHS, ELECTRODES, OBTURATORS, ENDOSCOPES	Jul 20, 1998	Substantially Equivalent	Richard Wolf Medical Instruments Corp.
K981828	GALILEO DISPOSABLE HYSTEROSCOPES	Jul 07, 1998	Substantially Equivalent	Netoptix Corp.
K981800	SENTINEL CHOLINESTERASE LIQUID MODEL NUMBER 17.019A & 17.606	Jul 06, 1998	Substantially Equivalent	Equal Diagnostics, Inc.
K971374	GREATBATCH SCIENTIFIC MR COMPATIBLE HYSTEROSCOPE	May 13, 1998	Substantially Equivalent	Wilson Greatbatch Technologies, Inc.
K974297	GALILEO DISPOSABLE HYSTEROSCOPES	Feb 13, 1998	Substantially Equivalent	Netoptix Corp.
K971420	MICROENDOSCOPE(8755.401,411,461,451)/EXTERNAL SHEATH(8755.221,222)/VERESS CANNULA(8755.211,212)	Oct 22, 1997	Substantially Equivalent	Richard Wolf Medical Instruments Corp.
K972426	MICROSPAN GOLD HYSTEROSCOPE AND MICROSPAN HYSTEROSCOPE SHEATH	Sep 23, 1997	Substantially Equivalent	Imagyn Medical, Inc.
K972210	RESECTOSCOPE SAFETY SHEATH	Sep 05, 1997	Substantially Equivalent	Conceptus, Inc.
K971305	FEMRX FOCUSED MONOPOLAR (FMP) OPERA STAR SYSTEM	Aug 11, 1997	Substantially Equivalent	Gynecare Innovation Center
K962271	ELECTROSURGICAL ELECRTRODES	Aug 08, 1997	Substantially Equivalent	Northgate Technologies, Inc.
K971518	KSEA SEMI-RIGID HYSTEROSCOPE AND ACCESSORIES	Jul 24, 1997	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K971188	SMITH & NEPHEW IMAGES ENDOSCOPES AND ACCESSORIS/SEMI-RIGID AND FLEXIBLE MANUAL INSTRUMENTS	Jun 27, 1997	Substantially Equivalent	Smith & Nephew, Inc.
K954488	ROLLER ELECTRODE	Mar 06, 1997	Substantially Equivalent	Olympus America, Inc.
K962256	GALILEO HYSTEROSCOPES AND LAPAROSCOPES	Dec 06, 1996	Substantially Equivalent	Galileo Electro-Optics Corp.
K961605	KARL STORZ 10.5 FR. FLEXIBLE HYSTEROSCOPE	Nov 13, 1996	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K962482	SCUBA SYSTEM	Nov 01, 1996	Substantially Equivalent	Gynecare, Inc.
K961688	MICROSPAN HYSTEROSCOPE	Oct 15, 1996	Substantially Equivalent	Imagyn Medical, Inc.
K961506	MICROSPAN HYSTEROSCOPE SHEATH	Jul 03, 1996	Substantially Equivalent	Imagyn Medical, Inc.
K954648	FEMRX OPERASTAR SYSTEM	Mar 14, 1996	Substantially Equivalent	Gynecare Innovation Center
K954164	HYSTEROSCOPE	Mar 12, 1996	Substantially Equivalent	Conceptus, Inc.
K952186	HSW GMBH HYSTEROSCOPES & ACCESSORIES	Feb 06, 1996	Substantially Equivalent	Henke-Sass, Wolf GmbH
K955119	SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROLLER ELECTRODES	Jan 18, 1996	Substantially Equivalent	Symbiosis Corp.
K951946	HYSTEROSYS FLEXIBLE HYSTEROCOPE	Nov 20, 1995	Substantially Equivalent	Ovamed Corp.
K940316	HYSTERSCOPE	Nov 16, 1995	Substantially Equivalent	Stephen Chakoff, Inc.
K935716	KARL STORZ FIXED MAGNIFICATION TELESCOPE/KS VARIABLE MAGNIFICATION TELESCOPE	Nov 16, 1995	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K952032	IMAGYN HYSTEROSCOPE SHEATHS	Oct 31, 1995	Substantially Equivalent	Imagyn Medical, Inc.
K952779	KARL STORZ FLEXIBLE HYSTERSCOPE	Oct 05, 1995	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K945265	OPTUS HYSTEROSCOPES AND CONTACT HYSTEROSCOPES	Sep 12, 1995	Substantially Equivalent	Optus, Inc.
K953109	HAND EXTRACTOR HECTOR	Aug 25, 1995	Substantially Equivalent	Karl Storz Endoscopy
K950255	ARGUS HYSTEROSCOPY INSTRUMENT SYSTEM	Aug 24, 1995	Substantially Equivalent	Argus Medical Co., Inc.
K952033	IMAGYN HYSTEROSCOPE	Jul 24, 1995	Substantially Equivalent	Imagyn Medical, Inc.
K933544	FUJINON VIDEO LAPORASCOPE	Apr 27, 1995	Substantially Equivalent	Fujinon, Inc.
K950055	A4722 OLYMPUS OPTICAL OBTURATOR	Feb 21, 1995	Substantially Equivalent	Olympus America, Inc.
K950036	OLYMPUS 5FR SEMI-RIGID SCISSORS FOR OB/GYN	Feb 09, 1995	Substantially Equivalent	Olympus America, Inc.
K934286	HYSTEROSCOPE	Jul 19, 1994	Substantially Equivalent	Bei Medical Systems Co., Inc.
K921942	HYSTEROSCOPE (AND ACCESSORIES)	Jun 24, 1994	Substantially Equivalent	Optimed Technologies, Inc.
K922420	CONTINUOUS FLOW HYSTERO-RESECTOSCOPE	Jun 14, 1994	Substantially Equivalent	Linvatec Corp.
K931764	HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES	Jun 08, 1994	Substantially Equivalent	Olympus Corp.
K922711	FLEXIBLE FIBER OPTIC GYNECOLOGIC ENDOSCOPE	May 17, 1994	Substantially Equivalent	Optimed Technologies, Inc.
K924631	CABOT MEDICAL UTERINE RESECTOSCOPE	May 16, 1994	Substantially Equivalent	Cabot Medical Corp.
K931994	RESECTOSCOPE SHEATH	Feb 17, 1994	Substantially Equivalent	Olympus Corp.
K914108	RG27-SERIES RESECTOSCOPE AND ACCESSORIES	Mar 19, 1992	Substantially Equivalent	CooperSurgical, Inc.
K905392	HT4-SERIES HYSTEROSCOPES AND ACCESSORIES	Apr 30, 1991	Substantially Equivalent	Frigitronics, Inc.
K903146	HYSTEROSCOPY SHEATH SET	Oct 12, 1990	Substantially Equivalent	Cook, Inc.
K895857	CONTINUOUS IRRIGATION RESECTOSCOPE SYST/GYNECOLOGY	Jun 22, 1990	Substantially Equivalent	Richard Wolf Medical Instruments Corp.
K897003	OLYMPUS HYSTERORESECTOSCOPE	Mar 16, 1990	Substantially Equivalent	Olympus Corp.
K896917	HYSTEROSCOPE	Mar 05, 1990	Substantially Equivalent	Cabot Medical Corp.
K890328	ADULT RESECTOSCOPE	Feb 06, 1990	Substantially Equivalent	Circon Video
K892390	FLEXIBLE IMMERSIBLE HYSTEROSCOPE	Feb 02, 1990	Substantially Equivalent	Schott Fiber Optics, Inc.
K882270	MODELS 27040 & 27050 CONTI. FLOW RESECTOSCOPES	Oct 20, 1989	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K891451	OLYMPUS HYF-P FLEXIBLE HYSTEROFIBERSCOPE	Oct 02, 1989	Substantially Equivalent	Olympus Corp.
K882761	TRANSERVICAL ENDOSCOPE (HYSTEROSCOPE)	Sep 20, 1988	Substantially Equivalent	Intramed Laboratories, Inc.
K880314	HYSTEROSCOPE AUTONOM 4992	Aug 25, 1988	Substantially Equivalent	Richard Wolf Medical Instruments Corp.
K881249	BAGGISH, HYSTEROSCOPE	Jul 28, 1988	Substantially Equivalent	Bryan Corp.
K841825	SCOPE LIGHT	Jun 15, 1984	Substantially Equivalent	Zinnanti Surgical Instruments, Inc.
K812202	FIBER OPTIC LIGHT SOURCE	Sep 29, 1981	Substantially Equivalent	Reznik Instruments
K811270	SCOPE MASTER	Sep 08, 1981	Substantially Equivalent	Synemed, Inc.
K810569	CONTACT-MICRO COLPOHYSTEROSCOPE	Jul 16, 1981	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K791330	HYSTEROSER	Mar 03, 1980	Substantially Equivalent	A. B. Vacuum Extractor, Inc.