510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K092726Substantially Equivalent

Mesh Gps - Large, Small, Sm, Sm Small

Surgical Structures, Ltd., Chalotte NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K092726 is the FDA 510(k) clearance record for MESH GPS - LARGE, SMALL, SM, SM SMALL, a class II device, cleared for Surgical Structures , Ltd. on under FDA product code OQL (Mesh, Surgical, Deployment Balloon). FDA's definition for product code OQL reads: "The device is intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of hernias". FDA records list one 510(k) clearance for Surgical Structures , Ltd. As of , FDA records show no recalls naming K092726.

Clearance record

Decision date
Received
(193 days to decision)
Product code
OQL Mesh, Surgical, Deployment Balloon
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Surgical Structures , Ltd. 1914 J.N. Pease Pl., Chalotte NC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OQL

Trailing 12 months

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

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