GEA · Cannula, Surgical, General & Plastic Surgery
General, Plastic Surgery · 21 CFR 878.4800 · Class 1
Overview
| Product Code | GEA |
|---|---|
| Device Name | Cannula, Surgical, General & Plastic Surgery |
| Regulation | 21 CFR 878.4800 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 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 § 878.9.
Recent Cleared Devices (20 of 36)
Showing 20 most recent of 36 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K003965 | MRI SAFE INSTRUMENTS | Aesculap, Inc. | Mar 16, 2001 | SESE |
| K982472 | GENICON TROCAR | Genicon, LC | Feb 4, 1999 | SESE |
| K954599 | CONMED TROGARD ELECTRONIC TROCAR SYSTEM | Conmedcorp | Nov 27, 1995 | SESE |
| K922460 | ORIGIN SECONDARY CANNULA AND TROCAR | Origin Medsystems, Inc. | Sep 16, 1992 | SESE |
| K920110 | ENDOPATH DISPOSABLE THORACIC TROCAR SLEEVE | ETHICON, Inc. | Apr 2, 1992 | SESE |
| K911262 | DISPOSABLE SPECIMEN BAG W/CANNULA AND INTRODUCER | ETHICON, Inc. | Jun 20, 1991 | SESE |
| K904881 | DISPOSABLE YANKAUER SUCTION TUBE | Pilling Medical S.A. | Mar 6, 1991 | SESE |
| K903416 | CANNULA, SURGICAL | Advantage Diagnostics Corp. | Nov 23, 1990 | SESE |
| K904218 | SUCTION SYSTEM | Axiom Medical, Inc. | Oct 31, 1990 | SESE |
| K901718 | KLEIN LAMPREY-CANNULA(TM) | Jeff Klein Surgical, Inc. | May 24, 1990 | SESE |
| K901717 | KLEIN MICRO-CANNULA(TM) | Jeff Klein Surgical, Inc. | May 24, 1990 | SESE |
| K901719 | KLEIN MICRO-CANNULA HANDLE(TM) | Jeff Klein Surgical, Inc. | May 22, 1990 | SESE |
| K895684 | SOFT SUCTION ADAPTER | Applied Medical Technologies | Nov 20, 1989 | SESE |
| K896434 | AUTO SUTURE SURGIPORT CANNULA DIAMETER REDUCER* | United States Surgical, A Division of Tyco Healthc | Nov 16, 1989 | SESE |
| K895762 | CANULA SUCTION FOR SURGICAL GENERAL AND PLASTIC | Kolster Methods | Oct 18, 1989 | SESE |
| K895670 | SURGICAL SUCTION APPARATUS | Baker-Sundt Research, Inc. | Sep 27, 1989 | SESE |
| K880669 | L-5 PLASTIC SURGERY CANNULAS | American Instrument Manufacturer'S, Inc. | Mar 17, 1988 | SESE |
| K872214 | COOPER SURG ASPIRATION CANNULA/CUSTOM CONVEN PAKS | CooperVision, Inc. | Aug 17, 1987 | SESE |
| K872906 | SUCTION TUBE TIP FITS OVER BUSSIE FRAZIER TUBE | American Silk Sutures, Inc. | Aug 11, 1987 | SESE |
| K871384 | APEX SUCTION CURETTE | Apex Medical, Inc. | May 22, 1987 | SESE |
Top Applicants
- ETHICON, Inc. — 3 clearances
- Jeff Klein Surgical, Inc. — 3 clearances
- Axiom Medical, Inc. — 2 clearances
- Wells Johnson Co. — 2 clearances
- Advanced Biosearch Assn. — 1 clearance
