510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K103269Substantially Equivalent

Patchassist Large

Polytouch Medical, Ltd., Providence RI / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K103269 is the FDA 510(k) clearance record for PATCHASSIST LARGE, a class II device, cleared for Polytouch Medical, Ltd. on under FDA product code ORQ (Mesh, Surgical, Deployer). FDA's definition for product code ORQ reads: "Intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of soft tissue defects (e.G. Hernia repair)". FDA records list 2 510(k) clearances for Polytouch Medical, Ltd., from to . As of , FDA records show no recalls naming K103269.

Clearance record

Decision date
Received
(19 days to decision)
Product code
ORQ Mesh, Surgical, Deployer
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Polytouch Medical, Ltd. 755 Westminster St., Providence RI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ORQ

Trailing 12 months

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

FDA records show no clearances under product code ORQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ORQ, 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