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ProGen PRP Eclipse PROGEN-A15

by Bimini Technologies LLC

ProGen PRP Eclipse PROGEN-A15 is a Class II device made by Bimini Technologies LLC, listed under FDA premarket submission BK170136 and listed in FDA GUDID since 4 Jan 2023 (UDI-DI 00850034511214), active as of 22 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 22 Oct 2026

Documents

510(k) BK170136

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850034511214 UDI-DI Date4 Jan 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberBK170136 Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA premarket submission BK170136 Active
  • FDA GUDID UDI-DI 00850034511214 listed 4 Jan 2023 Listed

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
ProGen PRP Eclipse
Generic name
Haematological concentrate system
Model / reference
PROGEN-A15
Primary DI / UDI-DI
00850034511214
FDA product code
ORG
GMDN term
Haematological concentrate system
Device class
Class II
Regulation number
864.9245
GUDID distribution status
In Commercial Distribution

Related devices

Category: Haematological concentrate system

Cleared under the same submission (BK170136)

and 8 more cleared under BK170136

Similar devices

Other devices filed under FDA product code ORG (Platelet And Plasma Separator For Bone Graft Handling).

Other devices from Bimini Technologies LLC

See all devices from Bimini Technologies LLC →

Properties

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