510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
OWTClass II

Mesh, Surgical, Absorbable, Abdominal Hernia

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

OWT is the FDA product code for Mesh, Surgical, Absorbable, Abdominal Hernia, 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 during hernia repair". As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
OWT
Device name
Mesh, Surgical, Absorbable, Abdominal Hernia
FDA definition
For reinforcement of soft tissue where weakness exists during hernia repair.
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
11
Ingested recalls
0

Clearances, product code OWT

By decision year
11 clearances under product code OWT with a decision year between 2003 and 2025, 2019 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code OWT by decision year
YearClearances
20031
20101
20121
20151
20171
20181
20192
20201
20241
20251

Applicants with the most clearances

Product code OWT
Applicants holding the most 510(k) clearances under product code OWT
ApplicantClearances
C.R. Bard Inc4
Novus Scientific AB2
W. L. Gore & Associates, Inc.2
Davol, Inc., A Subsidiary of C.R. Bard, Inc.1
Sofradim Production1
Tepha, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code