FDA Product Code GAA: Needle, Aspiration And Injection, Disposable
Leading manufacturers include Pneumeric, Inc., Bd Becton Dickinson Vacutainer Systems Preanalytic and Medline Industries, Inc..
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
Cleared
Mar 28, 2023
CapnoSpot™ Pneumothorax Decompression Indicator
Pneumeric, Inc.
General & Plastic Surgery
113d
Cleared
Jul 14, 1980
ACCU-CORE DISPOSABLE BIOPSY NEEDLE
Medline Industries, Inc.
General & Plastic Surgery
20d
Cleared
Nov 30, 1977
IOPSY TRAY FOR SOFT TISSUE BIOPSY
Bd Becton Dickinson Vacutainer Systems Preanalytic
General & Plastic Surgery
68d
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.