510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K250395Substantially Equivalent

BioBrace ® RC Delivery System

ConMed Corporation, Utica NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K250395 is the FDA 510(k) clearance record for BioBrace ® RC Delivery System, a class II device, cleared for Conmed Corporation 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 84 510(k) clearances for Conmed Corporation, from to . As of , FDA records show no recalls naming K250395.

Clearance record

Decision date
Received
(54 days to decision)
Product code
ORQ Mesh, Surgical, Deployer
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Conmed Corporation 525 French Rd., Utica NY
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