Xenmatrix AB Surgical Graft

Q: What is the product code of K133223?

The FDA product code is PIJ – Collagen Surgical Mesh Containing Drugs, a Class II (moderate risk) device regulated under 21 CFR 878.3300.

FDA 510(k) K133223 · C.R. Bard, Inc.

Substantially Equivalent

510(k) numberK133223

Submission

Device name: Xenmatrix AB Surgical Graft
Applicant: C.R. Bard, Inc.
Warwick, RI, US
Received: October 21, 2013
Decision date: September 19, 2014
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: PIJ – Collagen Surgical Mesh Containing Drugs
Device class: Class II (moderate risk)
Regulation: 21 CFR 878.3300
Specialty: General, Plastic Surgery
Implant: Yes

Reinforcement of soft tissue where weakness exists.

Other 510(k)s with product code PIJ

510(k)	Device	Applicant	Decision
K162193	XenMatrix AB Surgical GraftPIJ · Traditional	C. R. Bard	12/23/2016SE
K151177	XenMatrix AB Surgical GraftPIJ · Traditional	C. R. Bard	07/30/2015SE

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Questions and answers

When was Xenmatrix AB Surgical Graft cleared by the FDA?

Xenmatrix AB Surgical Graft (K133223) received a 510(k) decision of Substantially Equivalent on September 19, 2014, 333 days after the submission was received.

What is the product code of K133223?

The FDA product code is PIJ – Collagen Surgical Mesh Containing Drugs, a Class II (moderate risk) device regulated under 21 CFR 878.3300.