FZS · Curette, Surgical, General Use
General, Plastic Surgery · 21 CFR 878.4800 · Class 1
Overview
| Product Code | FZS |
|---|---|
| Device Name | Curette, Surgical, General Use |
| 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 (14 of 14)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K932493 | SURGICAL CURETTE | Whitney Products, Inc. | Jan 7, 1994 | SESE |
| K902000 | KEVTEK(TM) LASER DRAPE/ORGAN PROTECTOR/EYE SHIELD | Kevtek Medical Products, Inc. | Aug 21, 1990 | SESE |
| K892521 | CYMED MICROSKIN(R) DISPOSABLE IRRIGATION SLEEVE | Cymed, Inc. | May 1, 1989 | SESE |
| K891888 | CURRETTES - PIFFARD, WOLF, VIDAL-SCRAPER | Zinnanti Surgical Instruments, Inc. | Apr 12, 1989 | SESE |
| K891334 | ACU-CURETTE | Acuderm, Inc. | Apr 11, 1989 | SESE |
| K890366 | ADENOID CURETTE | Kinetic Medical Products | Feb 3, 1989 | SESE |
| K875292 | MICRODISCECTOMY CURETTE SET | T. Korossurgical Instruments Corp. | Jan 29, 1988 | SESE |
| K871925 | STRAIGHT CUP CURRETTE, 1.7MM | Arthropedics, Inc. | Jun 1, 1987 | SESE |
| K854899 | NOVAK CURETTE | Euro-Med Intl. | Dec 24, 1985 | SESE |
| K854888 | RANDALL CURETTE | Euro-Med Intl. | Dec 24, 1985 | SESE |
| K842701 | HOPPENSTEIN MICROSURGICAL SPINAL INSTRU | Downs Surgical , Ltd. | Aug 2, 1984 | SESE |
| K831367 | PMN VOLZ CURETTES | 3M Company | May 25, 1983 | SESE |
| K831119 | LUO CURRETTES #3211 | Pmt, Inc. | May 9, 1983 | SESE |
| K803178 | ANSPACH MENISECTOMY KNIFE | The Anspach Effort, Inc. | Feb 13, 1981 | SESE |
Top Applicants
- Euro-Med Intl. — 2 clearances
- 3M Company — 1 clearance
- Acuderm, Inc. — 1 clearance
- Arthropedics, Inc. — 1 clearance
- Cymed, Inc. — 1 clearance
