510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K162193Substantially Equivalent

XenMatrix AB Surgical Graft

Bard Access Systems, Inc., Warwick RI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K162193 is the FDA 510(k) clearance record for XenMatrix AB Surgical Graft, a class II device, cleared for C. R. Bard on under FDA product code PIJ (Collagen Surgical Mesh Containing Drugs). FDA's definition for product code PIJ reads: "Reinforcement of soft tissue where weakness exists". FDA records list 31 510(k) clearances for Bard Access Systems, Inc., from to . As of , FDA records show no recalls naming K162193.

Clearance record

Decision date
Received
(141 days to decision)
Product code
PIJ Collagen Surgical Mesh Containing Drugs
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
C. R. Bard 100 Crossings Blvd., Warwick RI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PIJ

Trailing 12 months

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

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