GAA · Needle, Aspiration And Injection, Disposable
General, Plastic Surgery · 21 CFR 878.4800 · Class 1
Overview
| Product Code | GAA |
|---|---|
| Device Name | Needle, Aspiration And Injection, Disposable |
| 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 107)
Showing 20 most recent of 107 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K223625 | CapnoSpot Pneumothorax Decompression Indicator | Pneumeric, Inc. | Mar 28, 2023 | SESE |
| K102274 | ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENT | Arvik Enterprises/ Mini Lap Technologies | Jun 15, 2011 | SESE |
| K011586 | IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE | Diametrics Medical, Inc. | Nov 16, 2001 | SESE |
| K994151 | PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES | Ximed/Prosure/Injectx | Mar 1, 2000 | SESE |
| K983200 | INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX | Ximed/Prosure/Injectx | Dec 11, 1998 | SESE |
| K974741 | MANAN ACCURA NEEDLE | Medical Device Technologies, Inc. | Jan 8, 1998 | SESE |
| K962425 | BONOPTY COAXIAL BONE BIOPSY SYSTEM WITH ECCENTRIC DRILL(10-1072,3,4) | Radi Medical Systems AB | Sep 11, 1996 | SESE |
| K961959 | MD TECH BIOPSY SET FOR BONE AND BONE MARROW | Medical Device Technologies, Inc. | Jul 19, 1996 | SESE |
| K945109 | MONOJECT BONE MARROW BIOPSY TRAYS | Sherwood Medical Co. | Nov 14, 1994 | SESE |
| K940025 | MANAN BONE MARROW HARVEST NEEDLES | Manan Medical Products, Inc. | Feb 25, 1994 | SESE |
| K940024 | MANAN GENERAL PURPOSE INTRODUCER NEEDLE | Manan Medical Products, Inc. | Feb 25, 1994 | SESE |
| K930158 | BONE MARROW BIOPSY PROCEDURE TRAY | Symbiosis Corp. | Jul 2, 1993 | SEKD |
| K925621 | IRRIGATION/ASPIRATION TUBING SET | Kirwan Surgical Products, Inc. | May 7, 1993 | SESE |
| K924501 | GILLAM-TUKEL BONE MARROW BIOPSY NEEDLE | Symbiosis Corp. | Apr 20, 1993 | SESE |
| K925416 | SYMBIOSIS BONE MARROW BIOPSY NEEDLE | Symbiosis Corp. | Feb 23, 1993 | SESE |
| K922614 | TURKEL THORACENTESIS SYSTEM | Symbiosis Corp. | Jul 30, 1992 | SESE |
| K915417 | KOPAN'S TARGET | Medical Device Technologies, Inc. | Jan 14, 1992 | SESE |
| K914608 | BREAST LES LOCAL WIRE ST. 48219/49220/48119/48120 | Dlp, Inc. | Jan 9, 1992 | SESE |
| K913992 | ASPIRATION/INJECTION NEEDLE | Northgate Technologies, Inc. | Oct 30, 1991 | SESE |
| K912074 | BONE MARROW BIOPSY TRAY | Manan Medical Products, Inc. | Aug 28, 1991 | SESE |
Top Applicants
- A.D.T. Lab Industries — 14 clearances
- Dlp, Inc. — 5 clearances
- Symbiosis Corp. — 4 clearances
- R. J. Doyle, Inc. — 4 clearances
- National Patent Development Corp. — 4 clearances
