HTZ · Instrument, Cutting, Orthopedic
General, Plastic Surgery · 21 CFR 878.4800 · Class 1
Overview
| Product Code | HTZ |
|---|---|
| Device Name | Instrument, Cutting, Orthopedic |
| 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 (21)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K933933 | CEBOPLANE | Synvasive Technology, Inc. | Apr 15, 1994 | SESE |
| K931737 | HEDLEYL INTRAMEDULLARY PREPARATION BRUSH | Synvasive Technology, Inc. | Jan 7, 1994 | SESE |
| K870882 | 45 DEGREE SHAVER | Bowen & Company, Inc. | Mar 23, 1987 | SESE |
| K853678 | KAMBIN SPINAL INSTRUMENT SET | Pilling Co. | Sep 24, 1985 | SESE |
| K850527 | ARTHROSCOPY SUCTION BIOPSY PUNCH | T. Korossurgical Instruments Corp. | Mar 14, 1985 | SESE |
| K850423 | CONCEPT SUCTION SLEEVE | Concept, Inc. | Mar 14, 1985 | SESE |
| K841980 | SIDE CUTTING SERRATED BLADE | Stainless Mfg., Inc. | Aug 15, 1984 | SESE |
| K842774 | CODMAN SUCTION PUNCH-PRODUCT CODES | Codman & Shurtleff, Inc. | Jul 27, 1984 | SESE |
| K842111 | KOGAN ENDOSPECULUM 9-1/2 | J. Sklar Mfg. Co., Inc. | Jun 19, 1984 | SESE |
| K841982 | MENISCOTOME 4MM & 5MM | Stainless Mfg., Inc. | Jun 19, 1984 | SESE |
| K841978 | LATERAL RELEASE KNIFE 5MM & 7MM | Stainless Mfg., Inc. | Jun 19, 1984 | SESE |
| K841977 | 5MM DOUGLE EDGE RING CURETTE | Stainless Mfg., Inc. | Jun 19, 1984 | SESE |
| K841976 | HOOK KNIFE 4MM & 5MM | Stainless Mfg., Inc. | Jun 19, 1984 | SESE |
| K841975 | ROSETTE KNIFE 4MM | Stainless Mfg., Inc. | Jun 19, 1984 | SESE |
| K841974 | RETROGRADE KNIFE 4MM & 5MM | Stainless Mfg., Inc. | Jun 19, 1984 | SESE |
| K841973 | BANANA KNIFE SERRATED | Stainless Mfg., Inc. | Jun 19, 1984 | SESE |
| K841972 | BANANA KNIFE - K841969-LABELING | Stainless Mfg., Inc. | Jun 19, 1984 | SESE |
| K831772 | GUILLOTINE BLADE | Ortho Pared Instruments, Inc. | Jul 7, 1983 | SESE |
| K771915 | MICRO OSCILLATING SAW | American Sterilizer Co. | Oct 21, 1977 | SESE |
| K771006 | MODIFIED PODIATRY PRODUCTS | Dentronix, Inc. | Jun 17, 1977 | SESE |
| K771005 | NEW PODIATRY PRODUCTS | Dentronix, Inc. | Jun 17, 1977 | SESE |
Top Applicants
- Stainless Mfg., Inc. — 9 clearances
- Synvasive Technology, Inc. — 2 clearances
- Dentronix, Inc. — 2 clearances
- T. Korossurgical Instruments Corp. — 1 clearance
- Pilling Co. — 1 clearance
