FZT · Cutter, Surgical
General, Plastic Surgery · 21 CFR 878.4800 · Class 1
Overview
| Product Code | FZT |
|---|---|
| Device Name | Cutter, Surgical |
| 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 52)
Showing 20 most recent of 52 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K112400 | SMARTSHEARS | Nuscience Consulting and Management Group, LLC | Sep 12, 2011 | SESE |
| K890818 | AUTO SUTURE DISPOSABLE SURGICAL TROCAR* | United States Surgical, A Division of Tyco Healthc | May 4, 1989 | SESE |
| K872990 | MICRINS SURGICAL SCISSOR | Micrins Surgical, Inc. | Aug 17, 1987 | SESE |
| K841741 | SINGLE HAIR TRANSPLANT GRAFT | Paris Products, Inc. | Jul 23, 1984 | SESE |
| K841247 | SPC DISPOSABLE CUTTER | Surgical Products Corp. | May 2, 1984 | SESE |
| K822448 | SCISSORS, VARIOUS | J. Sklar Mfg. Co., Inc. | Sep 14, 1982 | SESE |
| K821632 | SURGICAL SCISSORS, SET OF 3 | Fred Sammons, Inc. | Jun 24, 1982 | SESE |
| K821361 | CONPHAR TONSIL SCISSORS | Conphar, Inc. | May 27, 1982 | SESE |
| K821355 | CONPHAR LITTAUER SCISSORS | Conphar, Inc. | May 27, 1982 | SESE |
| K821352 | CONPHAR IRIS SCISSORS | Conphar, Inc. | May 27, 1982 | SESE |
| K821351 | CONPHAR DISSECTING SCISSORS | Conphar, Inc. | May 27, 1982 | SESE |
| K821350 | CONPHAR WIRE CUTTING SCISSORS | Conphar, Inc. | May 27, 1982 | SESE |
| K821126 | LISTER BANDAGE SCISSORS 3 & 1/2 | Conphar, Inc. | May 7, 1982 | SESE |
| K821125 | OPERATING SCISSORS 5 &1/2 SHARP BLUNT& | Conphar, Inc. | May 7, 1982 | SESE |
| K821124 | SCISSORS 6 & 1/2 SHARP/BLUNT | Conphar, Inc. | May 7, 1982 | SESE |
| K821123 | LISTER BANDAGE SCISSORS 7 & 1/2 | Conphar, Inc. | May 7, 1982 | SESE |
| K821122 | OPERATING 5 & 1/2 STRAIGH SHARP/BLUNT | Conphar, Inc. | May 7, 1982 | SESE |
| K821121 | SCISSORS 5 & 1/2STRAIGHT BLUNT/BLUNT | Conphar, Inc. | May 7, 1982 | SESE |
| K821120 | OPERATING SCISSORS CURVED 4 & 1/2 BLUNT | Conphar, Inc. | May 7, 1982 | SESE |
| K821119 | OPERATING SCISSORS 4 & 1/2 BLUNT/BLUNT | Conphar, Inc. | May 7, 1982 | SESE |
Top Applicants
- Conphar, Inc. — 21 clearances
- Dentronix, Inc. — 5 clearances
- Edward Weck, Inc. — 5 clearances
- Sea-Pac Trading Corp. — 4 clearances
- J. Sklar Mfg. Co., Inc. — 2 clearances
