510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K930825Substantially Equivalent

Suture Nonabsorbable-Nylon,silk,polyester,stainles

Surgical Specialties Corp, Readding PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K930825 is the FDA 510(k) clearance record for SUTURE NONABSORBABLE-NYLON,SILK,POLYESTER,STAINLES, a class II device, cleared for Surgical Specialties, Inc. on under FDA product code GAP (Suture, Nonabsorbable, Silk). FDA records list 33 510(k) clearances for Surgical Specialties, Inc., from to . As of , FDA records show one recall naming K930825.

Clearance record

Decision date
Received
(324 days to decision)
Product code
GAP Suture, Nonabsorbable, Silk
Regulation
21 CFR 878.5030
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Surgical Specialties, Inc. P.O. Box 310, Readding PA
510(k) summary
Statement
Third party review
No

Clearances, product code GAP

Trailing 12 months

FDA records hold no clearances under product code GAP in the trailing twelve months.

FDA records show no clearances under product code GAP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GAP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260