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GAB — Needle, Suturing, Disposable Class I

FDA Device Classification

Classification Details

Product Code
GAB
Device Class
Class I
Regulation Number
878.4800
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K012199humana usaDIGICAPDecember 19, 2001
K980988axya medicalAXYA MEDICAL, INC. AUTOMATIC SUTURING AND LIGATING SYSTEM-(ASLS)May 11, 1998
K932591synergistic medical technologiesENDO-JUDGEDecember 22, 1993
K895681applied medical technologiesCONTRAST BACKGROUND MATERIALOctober 24, 1989
K863595sharpointCOATED SUTURE NEEDLEOctober 24, 1986
K831648anchor productsANCHOR BRAND SURGICAL NEEDLESAugust 16, 1983
K812444devon industriesRADIATION STERILIZATION FOR NEEDLE CNTRDecember 14, 1981
K801976scanlan intlSCANLAN STERNUM NEEDLE-SUTURESeptember 26, 1980