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Graft Patch

by Organogenesis Inc.

510(k) K970561

Graft Patch is a Class II device made by Organogenesis Inc., cleared under FDA 510(k) K970561 on 1 Aug 1997, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK970561 Date1 Aug 1997ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
FTL
FDA applicant
Organogenesis, Inc.
Device class
Class II
Regulation
21 CFR Part 878.3300
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

Other devices from Organogenesis Inc.

See all devices from Organogenesis Inc. →