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ProGrip ADG2015

by Sofradim Production

ProGrip ADG2015 is a Class II device made by Sofradim Production, cleared under FDA 510(k) K253956 on 21 May 2026 and listed in FDA GUDID since 19 Jun 2026 (UDI-DI 10884521851689), 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) K253956

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 Number10884521851689 UDI-DI Date19 Jun 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK253956 Date21 May 2026DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K253956 decided 21 May 2026 Active
  • FDA GUDID UDI-DI 10884521851689 listed 19 Jun 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K253956
  2. Listed FDA GUDID 10884521851689

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
ProGrip
Generic name
Extra-gynaecological surgical mesh, composite-polymer
Model / reference
ADG2015
Primary DI / UDI-DI
10884521851689
510(k) Number
FDA product code
FTL
GMDN term
Extra-gynaecological surgical mesh, composite-polymer
Device class
Class II
Regulation number
878.3300
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe
Size
Width — 15 Centimeter
Length — 20 Centimeter

Related devices

Cleared under the same submission (K253956)

Similar devices

Other devices filed under FDA product code FTL (Mesh, surgical, polymeric).

Other devices from Sofradim Production

See all devices from Sofradim Production →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)