GAB · Class I · 21 CFR 878.4800

FDA Product Code GAB: Needle, Suturing, Disposable

Leading manufacturers include Humana USA, Inc., Scanlan Intl., Inc. and Devon Industries, Inc..

8
Total
8
Cleared
91d
Avg days
1980
Since

FDA 510(k) Cleared Needle, Suturing, Disposable Devices (Product Code GAB)

8 devices
1–8 of 8
Cleared Dec 19, 2001
DIGICAP
K012199
Humana USA, Inc.
General Hospital · 159d
Cleared May 11, 1998
AXYA MEDICAL, INC. AUTOMATIC SUTURING AND LIGATING SYSTEM-(ASLS)
K980988
Axya Medical, Inc.
General & Plastic Surgery · 55d
Cleared Dec 22, 1993
ENDO-JUDGE
K932591
Synergistic Medical Technologies, Inc.
General & Plastic Surgery · 208d
Cleared Oct 24, 1989
CONTRAST BACKGROUND MATERIAL
K895681
Applied Medical Technologies
General & Plastic Surgery · 33d
Cleared Oct 24, 1986
COATED SUTURE NEEDLE
K863595
Sharpoint, Inc.
General & Plastic Surgery · 39d
Cleared Aug 16, 1983
ANCHOR BRAND SURGICAL NEEDLES
K831648
Anchor Products Co.
General & Plastic Surgery · 85d
Cleared Dec 14, 1981
RADIATION STERILIZATION FOR NEEDLE CNTR
K812444
Devon Industries, Inc.
Radiology · 108d
Cleared Sep 26, 1980
SCANLAN STERNUM NEEDLE-SUTURE
K801976
Scanlan Intl., Inc.
General & Plastic Surgery · 38d

About Product Code GAB - Regulatory Context