DWO · Needle, Biopsy, Cardiovascular
General, Plastic Surgery · 21 CFR 878.4800 · Class 1
Overview
| Product Code | DWO |
|---|---|
| Device Name | Needle, Biopsy, Cardiovascular |
| 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 (11 of 11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K933364 | PROMED BIOPSY NEEDLE | Vlv Associates, Inc. | Feb 15, 1994 | SESE |
| K921418 | ULTRA-CORE BIOPSY NEEDLES | Medical Device Technologies, Inc. | Jun 19, 1992 | SESE |
| K913815 | AUTOMATED BIOPSY DEVICE, MODIFICATION | Hart Enterprises, Inc. | Oct 30, 1991 | SESE |
| K890925 | MANAN BONE MARROW BIOPSY NEEDLE | Manan Medical Products, Inc. | Apr 11, 1989 | SESE |
| K885145 | MEDSURG GREENE NEEDLE | Medsurg Industries, Inc. | Mar 14, 1989 | SESE |
| K885149 | NEEDLE INSERT FOR SOFT TISSUE BIOPSY DEVICE | Hart Enterprises, Inc. | Jan 26, 1989 | SESE |
| K882013 | SOFT TISSUE BIOPSY DEVICE | Ocean Medical Products, Ltd. | Jun 15, 1988 | SESE |
| K874585 | ANGIOMED OSTY-CUT BONE BIOPSY NEEDLE | Angiomed U.S., Inc. | Dec 2, 1987 | SESE |
| K872597 | FINE NEEDLE ASPIRATION BIOPSY SYSTEM-PROSTATE | Dianon Systems, Inc. | Jul 28, 1987 | SESE |
| K853312 | ARGON CUT BIOPSY NEEDLES, VARIOUS SIZES | Argon Medical Corp. | Sep 12, 1985 | SESE |
| K820269 | RNG SERIES ULTRASOUND NEEDLE/CATH. GDS | CIVCO Medical Instruments Co., Inc. | Mar 23, 1982 | SESE |
Top Applicants
- Hart Enterprises, Inc. — 2 clearances
- Angiomed U.S., Inc. — 1 clearance
- Argon Medical Corp. — 1 clearance
- CIVCO Medical Instruments Co., Inc. — 1 clearance
- Dianon Systems, Inc. — 1 clearance
