Product Code: KNA FDA class 2 21 CFR 884.4530

Instrument, Manual, Specialized Obstetric-Gynecologic

Obstetrics/Gynecology

A Specialized Manual Obstetric-Gynecologic Instrument is a hand-held surgical tool designed for specific obstetric or gynecologic procedures such as cervical biopsy, endometrial sampling, or other specialized interventions in the care of female reproductive health. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket notification. The product code is KNA and it is regulated under 21 CFR 884.4530 in the Obstetrics and Gynecology specialty.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code KNA in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: KNA
Device Class: FDA class 2
Regulation Number: 884.4530
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 58 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K130087	PANPAC WORD/BARTHOLIN CATHETER	Jan 10, 2014	Substantially Equivalent	Panpac Medical Corporation
K102141	COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)	May 06, 2011	Substantially Equivalent	Cook Urological, Inc.
K093904	GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER	Apr 14, 2010	Substantially Equivalent	Glenveigh Surgical, LLC
K082939	COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400	Sep 03, 2009	Substantially Equivalent	Cook Urological, Inc.
K062438	BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500	Oct 27, 2006	Substantially Equivalent	Cook Ob/Gyn
K060289	EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01	Jul 07, 2006	Substantially Equivalent	Frontline Medical
K013597	TAMPONADE UTERINE BALLOON CATHETER SET	Apr 17, 2002	Substantially Equivalent	Cook Ob/Gyn
K014248	DND 202 MANUAL UROLOGICAL DIGITAL NEEDLE DRIVER	Mar 21, 2002	Substantially Equivalent	Urogyn , Ltd.
K001590	DND 101	Aug 02, 2000	Substantially Equivalent	Urogyn , Ltd.
K990738	DR. JAHANGER'S CUTTER	Oct 29, 1999	Substantially Equivalent	M.S. Jahanger, MD
K990045	BERACLAMP, MODEL BC-1	May 24, 1999	Substantially Equivalent	Poamax LLC
K982464	SCC-23 SAFETY CLAMP AND CUTTER	Aug 11, 1998	Substantially Equivalent	Women First Healthcare, Inc.
K980717	UROMED SLING KIT	May 22, 1998	Substantially Equivalent	Uromed Corp.
K980237	GYNEX ENDOSPECULUM	Apr 08, 1998	Substantially Equivalent	Gynex Corp.
K972013	NATIONAL MEDICAL HEALTHCARE CUSTOM OB/GYN KITS, TRAYS, OR PACKS	Aug 26, 1997	Substantially Equivalent	National Healthcare Mfg. Corp.
K971277	SAFE-T-CLAMP	May 20, 1997	Substantially Equivalent	Talon Medical, Ltd.
K952527	BALLOON UTERINE STENT	Jan 02, 1996	Substantially Equivalent	Cook Urological, Inc.
K954619	CORDGUARD II	Dec 21, 1995	Substantially Equivalent	Utah Medical Products, Inc.
K951081	OB/GYN PACKS	Nov 13, 1995	Substantially Equivalent	Sterile Concepts, Inc.
K940907	MADDEN SURGICAL THIMBLE	Dec 29, 1994	Substantially Equivalent	Kelley-Gilmer Medical Corp.
K941641	DISPOSABLE EMERGENCY OBSTETRICAL KIT	Oct 03, 1994	Substantially Equivalent	Gam Industries, Inc.
K926532	ENDO CERVICAL CURETTE	Feb 25, 1994	Substantially Equivalent	Thomasville Medical Assoc.
K930727	VARIOUS SCISSORS	Feb 24, 1994	Substantially Equivalent	Thomasville Medical Assoc.
K930110	MICRO SURGERY NEEDLE HOLDERS	Feb 24, 1994	Substantially Equivalent	Thomasville Medical Assoc.
K930031	MICRO SURGERY SCISSORS	Feb 24, 1994	Substantially Equivalent	Thomasville Medical Assoc.
K926537	NEEDLE EXTENSIONS	Feb 24, 1994	Substantially Equivalent	Thomasville Medical Assoc.
K926530	MIYA HOOK	Feb 24, 1994	Substantially Equivalent	Thomasville Medical Assoc.
K926529	Z CLAMP SCISSORS	Feb 24, 1994	Substantially Equivalent	Thomasville Medical Assoc.
K930032	RETRACTOR RODS	Feb 10, 1994	Substantially Equivalent	Thomasville Medical Assoc.
K912075	C-SECTION TRAY	Apr 07, 1992	Unknown	Medical Device Inspection Co., Inc.
K891398	RETRACTOR RODS	May 11, 1989	Substantially Equivalent	Zinnanti Surgical Instruments, Inc.
K891399	CORSON MYOMA GRASPING FORCEPS	Mar 29, 1989	Substantially Equivalent	Zinnanti Surgical Instruments, Inc.
K891397	GREENE-ARMYTAGE HEMOSTATIC FORCEPS	Mar 29, 1989	Substantially Equivalent	Zinnanti Surgical Instruments, Inc.
K891048	OVUM FORCEPS-BARRET,JAVERTS,WILLET,HANSEN,COREY,MC	Mar 22, 1989	Substantially Equivalent	Zinnanti Surgical Instruments, Inc.
K891046	SOPHER AND BIERER OVUM FORCEPS	Mar 22, 1989	Substantially Equivalent	Zinnanti Surgical Instruments, Inc.
K891045	MIYA HOOK	Mar 22, 1989	Substantially Equivalent	Zinnanti Surgical Instruments, Inc.
K891042	MICRO SURGERY NEEDLE HOLDERS	Mar 17, 1989	Substantially Equivalent	Zinnanti Surgical Instruments, Inc.
K891040	MICRO SURGERY SCISSORS	Mar 17, 1989	Substantially Equivalent	Zinnanti Surgical Instruments, Inc.
K891039	MICRO SURGERY FORCEPS	Mar 17, 1989	Substantially Equivalent	Zinnanti Surgical Instruments, Inc.
K884291	COOK HYSTEROCATH(TM)	Dec 08, 1988	Substantially Equivalent	Cook, Inc.
K880497	WORD BARTHOLIN GLAND CATHETER CODE: 1005	Mar 24, 1988	Substantially Equivalent	Hoosier Specialties, Inc.
K863439	INTRAUTERINE HEMOSTASIS BALLOON STENT	Jun 02, 1987	Substantially Equivalent	Mentor Corp.
K871069	MODIFIED HYSTEROSALPINGOGRAPY SET	Apr 06, 1987	Substantially Equivalent	Ackrad Laboratories
K864623	OBSTETRICAL/GYNECOLOGICAL CUSTOM SURGICAL KIT	Jan 14, 1987	Substantially Equivalent	Xanmed Corp.
K861385	MILEX BARTHOLIN GLAND CATHETER	Jun 16, 1986	Substantially Equivalent	Milex Products, Inc.
K844823	MICROINFERTILITY FORCEPS, TITANIUM	Jan 16, 1985	Substantially Equivalent	Precision Surgical Instrument, Inc.
K844822	MICROINFERTILITY SCISSORS, TITANIUM	Jan 16, 1985	Substantially Equivalent	Precision Surgical Instrument, Inc.
K844821	MICROINFERTILITY NEEDLE HOLDER, TITANIUM	Jan 16, 1985	Substantially Equivalent	Precision Surgical Instrument, Inc.
K842231	ACKRAD HYSTEROSALPINGOGRAPHY SET	Sep 19, 1984	Substantially Equivalent	Ackrad Laboratories
K810484	OVARY FORCEPS	Mar 11, 1981	Substantially Equivalent	American V. Mueller
K810483	FALLOPIAN TUBE FORCEPS	Mar 11, 1981	Substantially Equivalent	American V. Mueller
K792631	STERILIZATION PROCESS/DBL. GRIP CORD CLP	Jan 28, 1980	Substantially Equivalent	Procter & Gamble Mfg. Co.
K790853	EASY-SPEC	Jul 30, 1979	Substantially Equivalent	C. Intl.
K790852	VAGI-SPEC	Jul 30, 1979	Substantially Equivalent	C. Intl.
K790923	MI-MARK ENDOCERVICAL SAMPLING SET	Jun 22, 1979	Substantially Equivalent	Simpson/Basye, Inc.
K780587	GYNESURG	May 25, 1978	Substantially Equivalent	Polamedco, Inc.
K770641	MINI-CONER TM	Jun 24, 1977	Substantially Equivalent	Medical Testing System, Inc.
K770727	MANIPULATOR & INJECTOR, UTERINE	Apr 26, 1977	Substantially Equivalent	National Catheter Co. Div. Mallinckrodt