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Gpc Ecpfat

by Gpc Medical, Ltd.

Gpc Ecpfat is a Class II device made by Gpc Medical, Ltd., cleared under FDA 510(k) K203811 on 10 Feb 2022 and listed in FDA GUDID since 19 Sep 2025 (UDI-DI 08905892042751), 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) K203811

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 Number08905892042751 UDI-DI Date19 Sep 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK203811 Date10 Feb 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K203811 decided 10 Feb 2022 Active
  • FDA GUDID UDI-DI 08905892042751 listed 19 Sep 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K203811
  2. Listed FDA GUDID 08905892042751

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Gpc
Generic name
Bone nail implantable cap
Model / reference
ECPFAT
Primary DI / UDI-DI
08905892042751
510(k) Number
FDA product code
HSB
GMDN term
Bone nail implantable cap
Device class
Class II
Regulation number
888.3020
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Bone nail end-cap

Cleared under the same submission (K203811)

and 8 more cleared under K203811

Other devices from Gpc Medical, Ltd.

See all devices from Gpc Medical, Ltd. →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (9, all answered No)