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Ventralight St Mesh

by Davol Inc., Sub. C. R. Bard, Inc. 510(k)

Active United States

510(k) K101851

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK101851 Date15 Jul 2010ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

2 recalls · FDA

    • Terminated Z-2413-2012 FDA Class II initiated 4 Sep 2012

    Mislabeled: The 8" x 10" package contains 7" x 9" VENTRALIGHT ST Mesh product and the 7" x 9" package contains 8" x 10" VENTRALIGHT ST Mesh

    • Terminated Z-2412-2012 FDA Class II initiated 4 Sep 2012

    Mislabeled: The 8" x 10" package contains 7" x 9" VENTRALIGHT ST Mesh product and the 7" x 9" package contains 8" x 10" VENTRALIGHT ST Mesh product

Specification

510(k)

510(k) Number
FDA Product Code
FTL
Device Class
Class II
Regulation
21 CFR Part 878.3300
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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