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

Silicone Hydrogel For Scar Management

21 CFR 878.4025 / General, Plastic Surgery
FDA source (opens on fda.gov)

PFP is the FDA product code for Silicone Hydrogel For Scar Management, a class I device type, regulated under 21 CFR 878.4025. FDA's definition for this code reads: "Management of closed hyperproliferative (hypertrophic and keloid) scars". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
PFP
Device name
Silicone Hydrogel For Scar Management
FDA definition
Management of closed hyperproliferative (hypertrophic and keloid) scars.
Regulation
21 CFR 878.4025
Device class
Class I
Review panel
General, Plastic Surgery
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code PFP

By decision year
1 clearance under product code PFP with a decision year between 2013 and 2013, 2013 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PFP by decision year
YearClearances
20131

Applicants with the most clearances

Product code PFP
Applicants holding the most 510(k) clearances under product code PFP
ApplicantClearances
Sonoma Pharmaceuticals, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 44 companies shown, in name order