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PuraForce ™ 550-004

by Organogenesis Inc.

PuraForce ™ 550-004 is a device classified as Unclassified made by Organogenesis Inc., cleared under FDA 510(k) K042809 on 2 Nov 2004 and listed in FDA GUDID since 17 Jul 2019 (UDI-DI 00618474000213), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K042809

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00618474000213 UDI-DI Date17 Jul 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK042809 Date2 Nov 2004DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K042809 decided 2 Nov 2004 Active
  • FDA GUDID UDI-DI 00618474000213 listed 17 Jul 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K042809
  2. Listed FDA GUDID 00618474000213

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
PuraForce ™
Generic name
Animal-derived wound matrix dressing
Model / reference
550-004
Primary DI / UDI-DI
00618474000213
510(k) Number
FDA product code
KGN
GMDN term
Animal-derived wound matrix dressing
Device class
U
GUDID distribution status
In Commercial Distribution
Size
Width — 3 Centimeter
Length — 6 Centimeter

Related devices

Category: Animal-derived wound matrix dressing

Cleared under the same submission (K042809)

Other devices from Organogenesis Inc.

See all devices from Organogenesis Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)