510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K922530Substantially Equivalent

Visitec Microsurgical Suture

Visitec Co., Sarasota FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K922530 is the FDA 510(k) clearance record for VISITEC MICROSURGICAL SUTURE, a class II device, cleared for Visitec Co. on under FDA product code GAR (Suture, Nonabsorbable, Synthetic, Polyamide). FDA records list 49 510(k) clearances for Visitec Co., from to . As of , FDA records show no recalls naming K922530.

Clearance record

Decision date
Received
(145 days to decision)
Product code
GAR Suture, Nonabsorbable, Synthetic, Polyamide
Regulation
21 CFR 878.5020
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Visitec Co. 7575 Commerce Ct., Sarasota FL
510(k) summary
Summary
Third party review
No

Clearances, product code GAR

Trailing 12 months
1 clearance under product code GAR in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GAR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260