Product Code: FDS FDA class 2 21 CFR 876.1500

Gastroscope And Accessories, Flexible/Rigid

Gastroenterology, Urology

The Gastroscope and Accessories (Flexible/Rigid) (product code FDS) is an endoscopic instrument used to examine or perform procedures in the stomach, including biopsy, polypectomy, and hemostasis. It is an FDA Class 2 device (moderate risk), requiring 510(k) premarket clearance. It is regulated under 21 CFR 876.1500 in the Gastroenterology and Urology specialty. For reusable flexible endoscopes of this type, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807).

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: FDS
Device Class: FDA class 2
Regulation Number: 876.1500
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

Definition

To examine or perform procedures in the stomach. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 75 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K260573	EvoEndo Single-Use Endoscopy System	Apr 21, 2026	Substantially Equivalent	EvoEndo, Inc.
K250550	FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit	Feb 17, 2026	Substantially Equivalent	Fujifilm Corporation
K253568	Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR	Feb 06, 2026	Substantially Equivalent	Fujifilm Corporation
K251256	PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family)	Dec 16, 2025	Substantially Equivalent	Pentax of America, Inc.
K251041	GripTract-GI Endoscopic Tissue Manipulator Upper GI Model GT-GS100	Oct 31, 2025	Substantially Equivalent	Actuated Medical, Inc.
K251708	EvoEndo Single-Use Endoscopy System	Oct 10, 2025	Substantially Equivalent	EvoEndo, Inc.
K243388	Disposable Distal Cap	Jun 27, 2025	Substantially Equivalent	Micro-Tech (Nanjing) Co., Ltd.
K250900	EvoEndo Single-Use Endoscopy System	Jun 16, 2025	Substantially Equivalent	EvoEndo, Inc.
K243512	FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP	Jun 10, 2025	Substantially Equivalent	Fujifilm Corporation
K242635	Endoscopic Distal Attachment (AF-D series)	May 30, 2025	Substantially Equivalent	Alton (Shanghai) Medical Instruments Co., Ltd.
K250296	Disposable Distal Attachment D-201 Series	May 01, 2025	Substantially Equivalent	Olympus Medical Systems Corp.
K241213	PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL)	Dec 06, 2024	Substantially Equivalent	Pentax of America, Inc.
K242779	Hood (DH-083ST)	Oct 11, 2024	Substantially Equivalent	Fujifilm Corporation
K240142	FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP	Sep 04, 2024	Substantially Equivalent	Fujifilm Corporation
K232997	EVIS Exera III Gastrointestinal Videoscope GIF-1TH190	Jun 19, 2024	Substantially Equivalent	Olympus Medical Systems Corporation
K232919	Ambu® aScope Gastro Large; Ambu® aBox 2	Apr 05, 2024	Substantially Equivalent	Ambu A/S
K232028	Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100)	Nov 17, 2023	Substantially Equivalent	Iq Endoscopes Limited
K232314	Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)	Sep 01, 2023	Substantially Equivalent	FUJIFILM Healthcare Americas Corporation
K221551	FUJIFILM Endoscope Model EI-740D/S	Jan 27, 2023	Substantially Equivalent	Fujifilm Corporaton
K213606	EvoEndo Single-Use Endoscopy System	Feb 14, 2022	Substantially Equivalent	EvoEndo, Inc.
K212382	Ambu® aScope Gastro, Ambu® aBox2	Feb 03, 2022	Substantially Equivalent	Ambu A/S
K210177	PENTAX Medical Video Upper GI Scopes EG17-J10	Oct 20, 2021	Substantially Equivalent	Pentax of America, Inc.
K212296	Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2	Aug 19, 2021	Substantially Equivalent	Fujifilm Corporation
K210915	Pathfinder Endoscope Cap	May 25, 2021	Substantially Equivalent	Neptune Medical, Inc.
K210485	PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC Family)	May 13, 2021	Substantially Equivalent	Pentax of America, Inc.
K210162	Endoscope Model EI-740D/S	Apr 09, 2021	Substantially Equivalent	Fujifilm Corporation
K192704	Endofresh Digestive Endoscopy System	Sep 02, 2020	Substantially Equivalent	Huizhou Xzing Technology Co., Ltd.
K200850	Fujifilm Ultrasonic Processor	Jul 06, 2020	Substantially Equivalent	Fujifilm Corporation
K193123	FUJIFILM Distal Cap Models 33-40	Dec 11, 2019	Substantially Equivalent	Fujifilm Corporation
K190799	PENTAX Medical Video Upper GI Scopes (EG Family)	Nov 12, 2019	Substantially Equivalent	Pentax of America, Inc.
K183572	FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L	Jul 16, 2019	Substantially Equivalent	Fujifilm Corporation
K182836	FUJIFILM Endoscope Model EG-740N	Apr 02, 2019	Substantially Equivalent	Fujifilm Corporation
K183686	FUJIFILM Endoscope Model EG-530N	Feb 28, 2019	Substantially Equivalent	Fujifilm Corporation
K180292	PENTAX Video Upper G.I. Scope EG34-i10	Oct 12, 2018	Substantially Equivalent	Pentax Medical of America, Inc.
K180341	FUJIFILM 600 Series Endoscope EG-600WR v2	Aug 03, 2018	Substantially Equivalent	Fujifilm Corporation
K181763	FUJIFILM Ultrasonic Endoscope	Jul 27, 2018	Substantially Equivalent	Fujifilm Corporation
K180911	Visura Technologies TEECAD System	Jun 20, 2018	Substantially Equivalent	Visura Technologies, LLC
K173004	SB Soft Hood - Straight type, SB Soft Hood - Undercut type	May 08, 2018	Substantially Equivalent	Sumitomo Bakelite Co., Ltd.
K172916	FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603	Mar 01, 2018	Substantially Equivalent	Fujifilm Corporation
K162749	FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR	Jun 15, 2017	Substantially Equivalent	Fujifilm Medical Systems U.S.A, Inc.
K153206	Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1	Mar 03, 2016	Substantially Equivalent	Fujifilm Medical System U.S.A., Inc.
K152182	Fuse Gastroscopy System	Dec 10, 2015	Substantially Equivalent	Endochoice, Inc.
K142629	EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes	May 14, 2015	Substantially Equivalent	Fujifilm Medical System U.S.A., Inc.
K140295	GIS ENDOSCOPIC OPTICAL LENS	Jul 24, 2014	Substantially Equivalent	Gi Scientific, LLC
K131902	PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY)	Apr 10, 2014	Substantially Equivalent	Pentax Medical Company
K131422	PEERSCOPE SYSTEM	Oct 10, 2013	Substantially Equivalent	Endochoice, Inc.
K130148	FOREIGN BODY HOOD	Aug 07, 2013	Substantially Equivalent	United States Endoscopy Group, Inc.
K123317	EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIXP190N	Dec 11, 2012	Substantially Equivalent	Olympus Medical Systems Corporation
K120446	FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2	Aug 13, 2012	Substantially Equivalent	Fujinon, Inc.
K113166	CLEARPATH UPPER GI	May 16, 2012	Substantially Equivalent	Easyglide , Ltd.
K111243	FUJINON ULTRASONIC PROCESSOR	May 16, 2011	Substantially Equivalent	Fujinon, Inc.
K093779	CLEARPATH UGI	Mar 09, 2010	Substantially Equivalent	Easyglide , Ltd.
K063316	FUJINON MODEL EG-530N TRANS NASAL INSERTION	Mar 16, 2007	Substantially Equivalent	Fujinon, Inc.
K063847	FUJINON ULTRASONIC ENDOSCOPE AND PROCESSOR, MODELS EG-530UR, EG-530UT AND SU-700	Mar 01, 2007	Substantially Equivalent	Fujinon, Inc.
K060907	KARL STORZ VIDEO GASTROSCOPES	Nov 09, 2006	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K042043	FUJINON INC. G5 GASTROSCOPES, MODELS EC-450WR5, EC-250WR5	Nov 24, 2004	Substantially Equivalent	Fujinon, Inc.
K032177	GASTROINTESTINAL VIDEOSCOPE XGIF-Q14OM, XGIF-2T140M COLONOVIDEOSCOPE XCF-Q14ML/I, XPCF-160AML/I	Oct 02, 2003	Substantially Equivalent	Olympus Opto-Electronics Co., Ltd.
K021886	OLYMPUS ULTRASONIC GASTROVIDEOSCOPE GF TYPE UC140P-DO5 & OLYMPUS ULTRASONIC GASTROFIBERSCOPE GF TYPE UC30P	Jun 19, 2002	Substantially Equivalent	Olympus Optical Co., Ltd.
K013640	EG-3630UR, ULTRASUND VIDEO GASTROSCOPE	Feb 04, 2002	Substantially Equivalent	Pentax Precision Instrument Corp.
K011151	EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z	May 15, 2001	Substantially Equivalent	The Olympus Optical Co.
K002231	LF-DP GASTROINTESTINAL AND SIGMOID FIBERSCOPE, ACCESSORIES AND ANCILLARY EQUIPMENT	Jan 30, 2001	Substantially Equivalent	Olympus Optical Co., Ltd.
K001766	OLYMPUS XGIF-N200H GASTROINTESTINAL VIDEOSCOPE	Sep 08, 2000	Substantially Equivalent	Olympus Optical Co., Ltd.
K984358	OLYMPUS DISTAL ATTACHMENT, MODELS MH-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-597	Sep 17, 1999	Substantially Equivalent	Olympus America, Inc.
K974493	FIEGERT ENDOTECH FLEXIBLE FIBEROPTIC ENDOSCOPES, FIEGERT ENDOTECH FLEXIBLE VIDEO-ENDOSCOPES	Mar 31, 1998	Substantially Equivalent	Fiegert-Endotech Medizintechnik GmbH
K971734	VG 200 VIDEO GASTROSCOPE	Jul 29, 1997	Substantially Equivalent	Welch Allyn, Inc.
K971660	OLYMPUS GF-UM130 ULTRASOUND GASTROVIDEOSCOPE, ITS ASSOCIATED ACCESSORIES AND ANCILLARY EQUIPMENT	Jul 25, 1997	Substantially Equivalent	Olympus America, Inc.
K963023	ULTRASOUND GASTROSCOPE GF TYPE UM30P	Feb 07, 1997	Substantially Equivalent	Olympus America, Inc.
K962897	EG-3400, VIDEO GASTROSCOPE	Oct 04, 1996	Substantially Equivalent	Pentax Precision Instrument Corp.
K962460	EG-3800T, VIDEO GASTROSCOPE	Sep 16, 1996	Substantially Equivalent	Pentax Precision Instrument Corp.
K961564	EG-2940, VIDEO GASTROSCOPE	Jul 09, 1996	Substantially Equivalent	Pentax Precision Instrument Corp.
K943715	VISION SYSTEM UPPER G.I. EXDOSCOPE	Feb 24, 1995	Substantially Equivalent	Vision-Sciences, Inc.
K933717	OLYMPUS MEASURING DEVICES	Nov 02, 1993	Substantially Equivalent	Olympus Corp.
K850020	PENTAX PNE- ULTRA-SLIM UPPER G.I. FIBERSCOPE FG-23	Jul 09, 1985	Substantially Equivalent	Pentax Precision Instrument Corp.
K833924	TWO CHANNEL GASTROFIBERSCOPE FG-36T	Feb 04, 1984	Substantially Equivalent	Pentax Precision Instrument Corp.
K832007	PENTAX FG-34JA GASTROFIBERSCOPE	Aug 11, 1983	Substantially Equivalent	Pentax Precision Instrument Corp.