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

Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery

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

OXF is the FDA product code for Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery, a class II device type, regulated under 21 CFR 878.3300. FDA's definition for this code reads: "For reinforcement of soft tissue where weakness exists in plastic and reconstructive surgery". As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
OXF
Device name
Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery
FDA definition
For reinforcement of soft tissue where weakness exists in plastic and reconstructive surgery.
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
8
Ingested recalls
0

Clearances, product code OXF

By decision year
8 clearances under product code OXF with a decision year between 2013 and 2025, 2017 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code OXF by decision year
YearClearances
20131
20172
20181
20221
20241
20252

Applicants with the most clearances

Product code OXF
Applicants holding the most 510(k) clearances under product code OXF
ApplicantClearances
W. L. Gore & Associates, Inc.3
Printbio, Inc.2
Acera Surgical, Inc. C/O Linda Braddon, PhD1
Allergan1
Sofregen Medical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code