Product Code: KOA FDA class 1 21 CFR 876.4730

Surgical Instruments, G-U, Manual (And Accessories)

Gastroenterology, Urology

Manual Genitourinary Surgical Instruments and Accessories are hand-held surgical tools used in urological and gastrointestinal surgical procedures, including forceps, scissors, dilators, and other instruments that facilitate tissue manipulation, dissection, and access in the urinary and gastrointestinal tracts. It is classified as FDA Class 1, indicating low risk subject to general controls with no premarket submission required. The product code is KOA and it is regulated under 21 CFR 876.4730 in the Gastroenterology and Urology specialty.

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510(k)s

FEI Numbers

113

Registration Numbers

113

Unique Applicants

Years Active

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Basic Information

Product Code: KOA
Device Class: FDA class 1
Regulation Number: 876.4730
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 4

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 44 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K182664	FiXcision	Dec 07, 2018	Substantially Equivalent	Agency For Medical Innovations GmbH
K950267	URETHRAL SUTURE GUIDE	Jan 31, 1995	Substantially Equivalent	Applied Medical Resources
K932465	LI VASECTOMY	Mar 02, 1994	Substantially Equivalent	Femcare , Ltd.
K921546	VASOVASOSTOMY SET	Jul 02, 1993	Unknown	Cook Urological, Inc.
K931181	VESITEC SUTURE PASSER	May 12, 1993	Substantially Equivalent	Vesitec Medical, Inc.
K921304	DDV LIGATOR	Oct 05, 1992	Substantially Equivalent	North American Medical, Inc.
K922971	NO-SCALPEL VASCETOMY INSTRUMENTS	Sep 23, 1992	Substantially Equivalent	Pilling Co.
K921228	BENDEREV PROTECT-A-PASS NEEDLE	Sep 14, 1992	Substantially Equivalent	Eimark Labs, Inc.
K922192	VAS DILATOR	Aug 07, 1992	Substantially Equivalent	Cook Urological, Inc.
K896058	GRASPING FORCEPS	Dec 28, 1989	Substantially Equivalent	Annex Medical, Inc.
K891352	MARLOW ANAL SPECULUM	Jun 23, 1989	Substantially Equivalent	Simpson/Basye, Inc.
K890218	MICROSURGICAL CYSTOTOME	Jan 27, 1989	Substantially Equivalent	Kinetic Medical Products
K864963	STOMACH EVACULATOR - EWALD STYLE	Oct 14, 1987	Substantially Equivalent	Medovations, Inc.
K863273	MARTIN MEDICAL PRO-SCOPE ANOSCOPE	Nov 04, 1986	Substantially Equivalent	Martin Medical
K852014	EFFNER SIMS RECTAL SPECULUM W/FIBER OPTIC ILLUMINA	Aug 07, 1985	Substantially Equivalent	Effner and Spreine Co.
K852726	ALLIS TISSUE FORCEPS, 4X5 TEETH, 6+SS 410 OR 420	Jul 09, 1985	Substantially Equivalent	The Huxley Instrument Corp.
K852725	BABCOCK TISSUE FORCEPS, 6-1/4 + SS 410 OR 420	Jul 09, 1985	Substantially Equivalent	The Huxley Instrument Corp.
K851162	AL ASKARI PERCUTANEOUS ACCESS NEEDLE HOLDER	Apr 15, 1985	Substantially Equivalent	Van-Tec, Inc.
K851113	RANDALL KIDNEY STONE FORCEPS 817-144 PCS. FULL CUR	Apr 03, 1985	Substantially Equivalent	The Huxley Instrument Corp.
K851112	RANDALL KIDNEY STONE FORCEPS 817-144 PCS. QUARTER	Apr 03, 1985	Substantially Equivalent	The Huxley Instrument Corp.
K851111	RANDALL KIDNEY STONE FORCEPS 817-84 PCS. HALF CURV	Apr 03, 1985	Substantially Equivalent	The Huxley Instrument Corp.
K841387	WESTON RECTAL SNARE	May 09, 1984	Substantially Equivalent	Imm Enterprises , Ltd.
K834171	OP-CON SURG. INSTRUMENT #3	Apr 04, 1984	Substantially Equivalent	Imm Enterprises , Ltd.
K834192	JAKOBI SURG. INSTRUMENTS #3 21/22/24	Mar 22, 1984	Substantially Equivalent	Imm Enterprises , Ltd.
K834191	JAKOBI SURGICAL INSTRUMENTS #3 17/18/19	Mar 22, 1984	Substantially Equivalent	Imm Enterprises , Ltd.
K841003	PROBES, VARIOUS	Mar 20, 1984	Substantially Equivalent	Premier Dental Products Co.
K832677	P-S MEDICAL BERLIN VISADUCT KIT	Dec 08, 1983	Substantially Equivalent	Pudenz-Schulte Medical Research Corp.
K830786	DISIMETRIC RELEASE OF INSTRANETICS RAD	May 18, 1983	Substantially Equivalent	American Convertors Div., American Pharmaseal
K822401	ST. MARK'S RECTAL BIOPSY FORCEPS	Aug 27, 1982	Substantially Equivalent	Keymed, Inc.
K820015	URETHAL CUTTER CLAMP	Feb 22, 1982	Substantially Equivalent	Lone Star Medical Products, Inc.
K813504	ACESSORY TO MODIFIED FREEDING JEJUNOSTO	Jan 07, 1982	Substantially Equivalent	Midwest Metabolic Support Group
K811973	FORDER RETRACTOR	Jul 31, 1981	Substantially Equivalent	Surgemed Marketing, Inc.
K811693	FORDER RETRACTOR	Jun 26, 1981	Substantially Equivalent	Dacomed Corp.
K811223	VASOVASOSTOMY STABILIZER PLATFORM DEV	May 21, 1981	Substantially Equivalent	Biomet, Inc.
K810915	THE SCOTT DIALMENZENSERT	May 08, 1981	Substantially Equivalent	Lone Star Medical Products, Inc.
K810533	CIRCLE NEPHROSTOMY TUBE INTRODUCER	Mar 11, 1981	Substantially Equivalent	American V. Mueller
K802983	THE INQUINAL RESORVOIR INSERTER	Dec 30, 1980	Substantially Equivalent	Lone Star Medical Products, Inc.
K801273	MAGILL CATHETER INTRO. FORCEPS	Jul 28, 1980	Substantially Equivalent	J. Sklar Mfg. Co., Inc.
K800441	RUDD-CLINIC HEMORRHOIDAL FORCEPS	Apr 08, 1980	Substantially Equivalent	J. Sklar Mfg. Co., Inc.
K772134	SYRINGE, IRRIGATION, PRE-FILLED	Nov 28, 1977	Substantially Equivalent	Kendall Research Center
K761229	ANAL/RECTAL SYRINGE	Feb 24, 1977	Substantially Equivalent	Ace Orthopedic Manufacturing Co.
K760717	FLEXIBLE BIOPSY FORCEPS	Oct 21, 1976	Substantially Equivalent	V. Mueller O.V. Baxter Healthcare Corp.
K760715	FLEXIBLE CUTTING SCISSORS	Oct 21, 1976	Substantially Equivalent	V. Mueller O.V. Baxter Healthcare Corp.
K760716	FLEXIBLE FOREIGN BODY FORCEPS	Oct 15, 1976	Substantially Equivalent	V. Mueller O.V. Baxter Healthcare Corp.