510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K022229Substantially Equivalent

Smartstitch Suture Device, Model Om-8500

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

K022229 is the FDA 510(k) clearance record for SMARTSTITCH SUTURE DEVICE, MODEL OM-8500, a class II device, cleared for Opus Medical, Inc. on under FDA product code OCW (Endoscopic Tissue Approximation Device). FDA's definition for product code OCW reads: "To aid in endoscopically placing sutures, staples, clips, and other fastening tools through tissue". FDA records list 13 510(k) clearances for Opus Medical, Inc., from to . As of , FDA records show 3 recalls naming K022229.

Clearance record

Decision date
Received
(58 days to decision)
Product code
OCW Endoscopic Tissue Approximation Device
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Opus Medical, Inc. 27127 Calle Arroyo, Suite 1924, San Juan Capistrano CA
510(k) summary
Statement
Third party review
No

Clearances, product code OCW

Trailing 12 months
1 clearance under product code OCW 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 OCW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260