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.
Recent Cleared Devices (20 of 44)
Showing 20 most recent of 44 cleared devices.
| 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 |
Top Applicants
- The Huxley Instrument Corp. — 5 clearances
- Imm Enterprises , Ltd. — 4 clearances
- Lone Star Medical Products, Inc. — 3 clearances
- V. Mueller O.V. Baxter Healthcare Corp. — 3 clearances
- Cook Urological, Inc. — 2 clearances
