510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K003102Substantially Equivalent

Pare Endoscopic Suturing System

Pare Surgical, Inc., Englewood CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K003102 is the FDA 510(k) clearance record for PARE ENDOSCOPIC SUTURING SYSTEM, a class II device, cleared for Pare Surgical, 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 one 510(k) clearance for Pare Surgical, Inc. As of , FDA records show no recalls naming K003102.

Clearance record

Decision date
Received
(146 days to decision)
Product code
OCW Endoscopic Tissue Approximation Device
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Pare Surgical, Inc. 7332 S. Alton Way, Unit H, Englewood CO
510(k) summary
Summary
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