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

Collagen Surgical Mesh Containing Drugs

21 CFR 878.3300 / General, Plastic Surgery
FDA source (opens on fda.gov)

PIJ is the FDA product code for Collagen Surgical Mesh Containing Drugs, a class II device type, regulated under 21 CFR 878.3300. FDA's definition for this code reads: "Reinforcement of soft tissue where weakness exists". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PIJ
Device name
Collagen Surgical Mesh Containing Drugs
FDA definition
Reinforcement of soft tissue where weakness exists.
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code PIJ

By decision year
3 clearances under product code PIJ with a decision year between 2014 and 2016, 2014 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PIJ by decision year
YearClearances
20141
20151
20161

Applicants with the most clearances

Product code PIJ
Applicants holding the most 510(k) clearances under product code PIJ
ApplicantClearances
Bard Access Systems, Inc.2
C.R. Bard Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code