GAO — Suture, Nonabsorbable Class II

FDA Device Classification

FDA product code GAO covers "Suture, Nonabsorbable", a Class II medical device regulated under 21 CFR 878.4495. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants. At least 4 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
GAO
Device Class
Class II
Regulation Number
878.4495
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K932513alto developmentLABELING FOR MYO/WIRE II STERNOTOMY SUTURESJanuary 7, 1994
K872532united states surgical, a division of tyco healthcAUTO SUTURE STAINLESS STEEL SUTURES*August 5, 1987
K863034chathamborough research groupSHARPOINT STAINLESS STEEL SUTURESeptember 30, 1986
K802248unoplastDISARP ORIGINALSeptember 26, 1980