510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K042031Substantially Equivalent

Opus Speedstitch Suture Device

Opus Medical, Inc., San Juan Capistrano CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K042031 is the FDA 510(k) clearance record for OPUS SPEEDSTITCH SUTURE DEVICE, a class II device, cleared for Opus Medical, Inc. on under FDA product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene). FDA records list 13 510(k) clearances for Opus Medical, Inc., from to . As of , FDA records show one recall naming K042031.

Clearance record

Decision date
Received
(83 days to decision)
Product code
GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Regulation
21 CFR 878.5000
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Opus Medical, Inc. 27127 Calle Arroyo, Suite 1924, San Juan Capistrano CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GAT

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