FZX · Guide, Surgical, Instrument
General, Plastic Surgery · 21 CFR 878.4800 · Class 1
Overview
| Product Code | FZX |
|---|---|
| Device Name | Guide, Surgical, Instrument |
| 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.
Cleared Devices (19)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K914715 | PARALLELING GUIDES | Implant Corp. of America | Feb 16, 1994 | SESE |
| K871413 | CIVCO STEPPER | CIVCO Medical Instruments Co., Inc. | Jul 14, 1987 | SESE |
| K871503 | BIOPSY NEEDLE GUIDE KIT, STERILE | Amedic USA | Jul 10, 1987 | SESE |
| K862564 | A.C.L. GUIDE KIT | Aspen Laboratories, Inc. | Aug 18, 1986 | SESE |
| K854262 | MEADOX SURGIMED BREAST LOCALIZATION WIRE SET/ONLY | Meadox Surgimed, Inc. | Dec 24, 1985 | SESE |
| K852402 | NAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZER | North American Instrument Corp. | Jul 11, 1985 | SESE |
| K842698 | BRITISH SPINAL FUSION SET | Downs Surgical , Ltd. | Sep 12, 1984 | SESE |
| K841618 | THREADING TUBE | Plastafil, Inc. | Aug 27, 1984 | SESE |
| K841619 | DRILL GUIDE | Plastafil, Inc. | Jul 11, 1984 | SESE |
| K841297 | TECHMEDICA DRILL GUIDE | Techmedica, Inc. | Apr 25, 1984 | SESE |
| K840835 | STRAITH DRAIN INSERTER | Surgical Technology Laboratories, Inc. | Apr 23, 1984 | SESE |
| K834350 | ACUFEX DREZ COMMUNICATING DRILL GUIDE | Acufex Microsurgical, Inc. | Mar 19, 1984 | SESE |
| K830720 | GRAF MENISCAL SUTURE SET | Acufex Microsurgical, Inc. | Jun 16, 1983 | SESE |
| K821618 | DISPOSABLE NEEDLE HOLDERS | Medcare Products | Jun 21, 1982 | SESE |
| K810888 | BOUNDARY TUBING HOLDERS | The Buckeye Cellulose Corp. | Apr 23, 1981 | SESE |
| K810788 | SURGICAL TUBE HOLDER | The Urology Group | Apr 17, 1981 | SESE |
| K802093 | GABBAY-FRATER SUTURE GUIDE | Howmedica Corp. | Sep 26, 1980 | SESE |
| K792468 | FEEDING TUBE PLACEMENT STYLET | Biosearch Medical Products, Inc. | Dec 27, 1979 | SESE |
| K790872 | ENTERIC TUBE GUIDE | Biosearch Medical Products, Inc. | May 23, 1979 | SESE |
Top Applicants
- Plastafil, Inc. — 2 clearances
- Biosearch Medical Products, Inc. — 2 clearances
- Acufex Microsurgical, Inc. — 2 clearances
- The Urology Group — 1 clearance
- The Buckeye Cellulose Corp. — 1 clearance
