KOA · Surgical Instruments, G-U, Manual (And Accessories)
Gastroenterology, Urology · 21 CFR 876.4730 · Class 1
Overview
| Product Code | KOA |
|---|---|
| Device Name | Surgical Instruments, G-U, Manual (And Accessories) |
| Regulation | 21 CFR 876.4730 |
| Device Class | Class 1 |
| Review Panel | Gastroenterology, Urology |
Identification
A manual gastroenterology-urology surgical instrument and accessories is a device designed to be used for gastroenterological and urological surgical procedures. The device may be nonpowered, hand-held, or hand-manipulated. Manual gastroenterology-urology surgical instruments include the biopsy forceps cover, biopsy tray without biopsy instruments, line clamp, nonpowered rectal probe, nonelectrical clamp, colostomy spur-crushers, locking device for intestinal clamp, needle holder, gastro-urology hook, gastro-urology probe and director, nonself-retaining retractor, laparotomy rings, nonelectrical snare, rectal specula, bladder neck spreader, self-retaining retractor, and scoop. A manual surgical instrument that is intended specifically for use as an aid in the insertion, placement, fixation, or anchoring of surgical mesh during urogynecologic procedures are classified under § 884.4910 of this chapter.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
Cleared Devices (44)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K182664 | FiXcision | Agency For Medical Innovations GmbH | Dec 7, 2018 | SESE |
| K950267 | URETHRAL SUTURE GUIDE | Applied Medical Resources | Jan 31, 1995 | SESE |
| K932465 | LI VASECTOMY | Femcare , Ltd. | Mar 2, 1994 | SESE |
| K921546 | VASOVASOSTOMY SET | Cook Urological, Inc. | Jul 2, 1993 | SESK |
| K931181 | VESITEC SUTURE PASSER | Vesitec Medical, Inc. | May 12, 1993 | SESE |
| K921304 | DDV LIGATOR | North American Medical, Inc. | Oct 5, 1992 | SESE |
| K922971 | NO-SCALPEL VASCETOMY INSTRUMENTS | Pilling Co. | Sep 23, 1992 | SESE |
| K921228 | BENDEREV PROTECT-A-PASS NEEDLE | Eimark Labs, Inc. | Sep 14, 1992 | SESE |
| K922192 | VAS DILATOR | Cook Urological, Inc. | Aug 7, 1992 | SESE |
| K896058 | GRASPING FORCEPS | Annex Medical, Inc. | Dec 28, 1989 | SESE |
| K891352 | MARLOW ANAL SPECULUM | Simpson/Basye, Inc. | Jun 23, 1989 | SESE |
| K890218 | MICROSURGICAL CYSTOTOME | Kinetic Medical Products | Jan 27, 1989 | SESE |
| K864963 | STOMACH EVACULATOR - EWALD STYLE | Medovations, Inc. | Oct 14, 1987 | SESE |
| K863273 | MARTIN MEDICAL PRO-SCOPE ANOSCOPE | Martin Medical | Nov 4, 1986 | SESE |
| K852014 | EFFNER SIMS RECTAL SPECULUM W/FIBER OPTIC ILLUMINA | Effner and Spreine Co. | Aug 7, 1985 | SESE |
| K852726 | ALLIS TISSUE FORCEPS, 4X5 TEETH, 6+SS 410 OR 420 | The Huxley Instrument Corp. | Jul 9, 1985 | SESE |
| K852725 | BABCOCK TISSUE FORCEPS, 6-1/4 + SS 410 OR 420 | The Huxley Instrument Corp. | Jul 9, 1985 | SESE |
| K851162 | AL ASKARI PERCUTANEOUS ACCESS NEEDLE HOLDER | Van-Tec, Inc. | Apr 15, 1985 | SESE |
| K851113 | RANDALL KIDNEY STONE FORCEPS 817-144 PCS. FULL CUR | The Huxley Instrument Corp. | Apr 3, 1985 | SESE |
| K851112 | RANDALL KIDNEY STONE FORCEPS 817-144 PCS. QUARTER | The Huxley Instrument Corp. | Apr 3, 1985 | SESE |
| K851111 | RANDALL KIDNEY STONE FORCEPS 817-84 PCS. HALF CURV | The Huxley Instrument Corp. | Apr 3, 1985 | SESE |
| K841387 | WESTON RECTAL SNARE | Imm Enterprises , Ltd. | May 9, 1984 | SESE |
| K834171 | OP-CON SURG. INSTRUMENT #3 | Imm Enterprises , Ltd. | Apr 4, 1984 | SESE |
| K834192 | JAKOBI SURG. INSTRUMENTS #3 21/22/24 | Imm Enterprises , Ltd. | Mar 22, 1984 | SESE |
| K834191 | JAKOBI SURGICAL INSTRUMENTS #3 17/18/19 | Imm Enterprises , Ltd. | Mar 22, 1984 | SESE |
| K841003 | PROBES, VARIOUS | Premier Dental Products Co. | Mar 20, 1984 | SESE |
| K832677 | P-S MEDICAL BERLIN VISADUCT KIT | Pudenz-Schulte Medical Research Corp. | Dec 8, 1983 | SESE |
| K830786 | DISIMETRIC RELEASE OF INSTRANETICS RAD | American Convertors Div., American Pharmaseal | May 18, 1983 | SESE |
| K822401 | ST. MARK'S RECTAL BIOPSY FORCEPS | Keymed, Inc. | Aug 27, 1982 | SESE |
| K820015 | URETHAL CUTTER CLAMP | Lone Star Medical Products, Inc. | Feb 22, 1982 | SESE |
| K813504 | ACESSORY TO MODIFIED FREEDING JEJUNOSTO | Midwest Metabolic Support Group | Jan 7, 1982 | SESE |
| K811973 | FORDER RETRACTOR | Surgemed Marketing, Inc. | Jul 31, 1981 | SESE |
| K811693 | FORDER RETRACTOR | Dacomed Corp. | Jun 26, 1981 | SESE |
| K811223 | VASOVASOSTOMY STABILIZER PLATFORM DEV | Biomet, Inc. | May 21, 1981 | SESE |
| K810915 | THE SCOTT DIALMENZENSERT | Lone Star Medical Products, Inc. | May 8, 1981 | SESE |
| K810533 | CIRCLE NEPHROSTOMY TUBE INTRODUCER | American V. Mueller | Mar 11, 1981 | SESE |
| K802983 | THE INQUINAL RESORVOIR INSERTER | Lone Star Medical Products, Inc. | Dec 30, 1980 | SESE |
| K801273 | MAGILL CATHETER INTRO. FORCEPS | J. Sklar Mfg. Co., Inc. | Jul 28, 1980 | SESE |
| K800441 | RUDD-CLINIC HEMORRHOIDAL FORCEPS | J. Sklar Mfg. Co., Inc. | Apr 8, 1980 | SESE |
| K772134 | SYRINGE, IRRIGATION, PRE-FILLED | Kendall Research Center | Nov 28, 1977 | SESE |
| K761229 | ANAL/RECTAL SYRINGE | Ace Orthopedic Manufacturing Co. | Feb 24, 1977 | SESE |
| K760717 | FLEXIBLE BIOPSY FORCEPS | V. Mueller O.V. Baxter Healthcare Corp. | Oct 21, 1976 | SESE |
| K760715 | FLEXIBLE CUTTING SCISSORS | V. Mueller O.V. Baxter Healthcare Corp. | Oct 21, 1976 | SESE |
| K760716 | FLEXIBLE FOREIGN BODY FORCEPS | V. Mueller O.V. Baxter Healthcare Corp. | Oct 15, 1976 | SESE |
Top Applicants
- The Huxley Instrument Corp. — 5 clearances
- Imm Enterprises , Ltd. — 4 clearances
- V. Mueller O.V. Baxter Healthcare Corp. — 3 clearances
- Lone Star Medical Products, Inc. — 3 clearances
- J. Sklar Mfg. Co., Inc. — 2 clearances
