GAA · Class I · 21 CFR 878.4800

FDA Product Code GAA: Needle, Aspiration And Injection, Disposable

Leading manufacturers include A.D.T. Lab Industries, Dlp, Inc. and Symbiosis Corp..

107
Total
107
Cleared
54d
Avg days
1976
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Needle, Aspiration And Injection, Disposable Devices (Product Code GAA)

107 devices
1–24 of 107
Cleared Mar 28, 2023
CapnoSpot™ Pneumothorax Decompression Indicator
K223625
Pneumeric, Inc.
General & Plastic Surgery · 113d
Cleared Mar 01, 2000
PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES
K994151
Ximed/Prosure/Injectx
General & Plastic Surgery · 83d
Cleared Dec 11, 1998
INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX
K983200
Ximed/Prosure/Injectx
General & Plastic Surgery · 88d
Cleared Jan 08, 1998
MANAN ACCURA NEEDLE
K974741
Medical Device Technologies, Inc.
General & Plastic Surgery · 20d
Cleared Sep 11, 1996
BONOPTY COAXIAL BONE BIOPSY SYSTEM WITH ECCENTRIC DRILL(10-1072,3,4)
K962425
Radi Medical Systems AB
General & Plastic Surgery · 79d
Cleared Jul 19, 1996
MD TECH BIOPSY SET FOR BONE AND BONE MARROW
K961959
Medical Device Technologies, Inc.
General & Plastic Surgery · 60d
Cleared Nov 14, 1994
MONOJECT BONE MARROW BIOPSY TRAYS
K945109
Sherwood Medical Co.
General & Plastic Surgery · 27d
Cleared Feb 25, 1994
MANAN GENERAL PURPOSE INTRODUCER NEEDLE
K940024
Manan Medical Products, Inc.
General & Plastic Surgery · 53d
Cleared Feb 25, 1994
MANAN BONE MARROW HARVEST NEEDLES
K940025
Manan Medical Products, Inc.
General & Plastic Surgery · 53d
Cleared Jul 02, 1993
BONE MARROW BIOPSY PROCEDURE TRAY
K930158
Symbiosis Corp.
General & Plastic Surgery · 170d
Cleared May 07, 1993
IRRIGATION/ASPIRATION TUBING SET
K925621
Kirwan Surgical Products, Inc.
General & Plastic Surgery · 182d
Cleared Apr 20, 1993
GILLAM-TUKEL BONE MARROW BIOPSY NEEDLE
K924501
Symbiosis Corp.
General & Plastic Surgery · 228d
Cleared Feb 23, 1993
SYMBIOSIS BONE MARROW BIOPSY NEEDLE
K925416
Symbiosis Corp.
General & Plastic Surgery · 119d
Cleared Jul 30, 1992
TURKEL THORACENTESIS SYSTEM
K922614
Symbiosis Corp.
General & Plastic Surgery · 58d
Cleared Jan 14, 1992
KOPAN'S TARGET
K915417
Medical Device Technologies, Inc.
General & Plastic Surgery · 43d
Cleared Jan 09, 1992
BREAST LES LOCAL WIRE ST. 48219/49220/48119/48120
K914608
Dlp, Inc.
General & Plastic Surgery · 84d
Cleared Oct 30, 1991
ASPIRATION/INJECTION NEEDLE
K913992
Northgate Technologies, Inc.
General & Plastic Surgery · 55d
Cleared Aug 28, 1991
BONE MARROW BIOPSY TRAY
K912074
Manan Medical Products, Inc.
General & Plastic Surgery · 110d
Cleared Apr 04, 1991
SURG TECH,INC. 30 GAUGE STRAIGHT EXTRUSION NEEDLES
K910036
Surgical Technologies, Inc.
General & Plastic Surgery · 90d
Cleared May 24, 1990
SURE-STOP TRANSBRONCHIAL ASPIRATION NEEDLE
K901438
Telemed Systems, Inc.
General & Plastic Surgery · 59d
Cleared Apr 16, 1990
WILSON-COOK LUNG BIOPSY NEEDLE
K897050
Wilson-Cook Medical, Inc.
General & Plastic Surgery · 119d
Cleared Jan 03, 1990
MODIFIED DISP. CHIBA-TYPE NEEDLE DESIGNATED ASPI.
K896019
Dlp, Inc.
General & Plastic Surgery · 79d
Cleared Dec 27, 1989
E-Z-EM VACUUM ASPIRATION SYRINGE
K895012
E-Z-Em, Inc.
General & Plastic Surgery · 141d
Cleared Jul 24, 1989
THORACENTISIS KIT
K894326
Mill-Rose Laboratory
General & Plastic Surgery · 10d

About Product Code GAA - Regulatory Context

510(k) Submission Activity

107 total 510(k) submissions under product code GAA since 1976, with 107 receiving FDA clearance (average review time: 54 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.