GES · Blade, Scalpel
General, Plastic Surgery · 21 CFR 878.4800 · Class 1
Overview
| Product Code | GES |
|---|---|
| Device Name | Blade, Scalpel |
| 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 48)
Showing 20 most recent of 48 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K032242 | PERSONNA PLUS SAFETY SCALPEL SYSTEM | Omi Manufacturing Pty., Ltd. | Sep 23, 2003 | SESE |
| K932998 | EASY-ON | Devon Industries, Inc. | Aug 18, 1993 | SESE |
| K923170 | LOS ALAMOS RETRACTABLE KNIFE | Innovative Surgical Technology, Inc. | Feb 18, 1993 | SESE |
| K915119 | SCALPEL BLADE REMOVER (BLADEGARD) | Intergrated Visual, Inc. | May 5, 1992 | SESE |
| K911913 | PRECISION GLIDE - ENHANCED SURGICAL BLADE | Bd Becton Dickinson Vacutainer Systems Preanalytic | May 13, 1991 | SESE |
| K900266 | STERILE CARBON STEEL SURGICAL BLADE | Rahn Laboratories | Mar 1, 1990 | SESE |
| K884862 | ANCHOR DOUBLE-EDGE MYRINGOTOMY BLADE | Anchor Products Co. | Dec 27, 1988 | SESE |
| K881638 | SURGICAL BLADE | Far East Intl. Trading Corp. | Jun 15, 1988 | SESE |
| K880244 | SURGICAL BLADES | Ailee C/O Havel'S, Inc. | Feb 10, 1988 | SESE |
| K873493 | NINJA SCALPEL | Primrose Medical, Inc. | Sep 24, 1987 | SESE |
| K873142 | PERSONNA DISPOSABLE SCALPEL | American Safety Razor Co. | Sep 4, 1987 | SESE |
| K863885 | SABLE BLADES | Sable Industries | Oct 24, 1986 | SESE |
| K863867 | DEXTRA DISPOSABLE BLADES | Storz Instrument Co. | Oct 24, 1986 | SESE |
| K863214 | KEISEI MICRO-BLADES (STERILE AND NON-STERILE) | Keisei Medical Industrial Co., Ltd. | Sep 2, 1986 | SESE |
| K863211 | KEISEI SURGICAL BLADES (STERILE & NON-STERILE) | Keisei Medical Industrial Co., Ltd. | Sep 2, 1986 | SESE |
| K855104 | ANGIOMED SKIN FASCIA KNIFE | Angiomed U.S., Inc. | Jan 24, 1986 | SESE |
| K854860 | BLADES, SCALPEL CARBON STEET | Medelec Intl. Corp. | Dec 24, 1985 | SESE |
| K854859 | BLADES, SCALPEL STAINLESS STEEL | Medelec Intl. Corp. | Dec 24, 1985 | SESE |
| K854620 | SURGICAL BLADES | Niraj Industries | Dec 17, 1985 | SESE |
| K854561 | BLADE, SCALPEL | Medelec Intl. Corp. | Dec 2, 1985 | SESE |
Top Applicants
- Aeroceuticals — 4 clearances
- Imm Enterprises , Ltd. — 3 clearances
- Medelec Intl. Corp. — 3 clearances
- American Safety Razor Co. — 2 clearances
- Keisei Medical Industrial Co., Ltd. — 2 clearances
