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Puregraft SYNC PURE/SYNC

by Bimini Technologies LLC

Puregraft SYNC PURE/SYNC is a Class II device made by Bimini Technologies LLC, listed under FDA premarket submission BK251296 and listed in FDA GUDID since 24 Feb 2026 (UDI-DI 00850034511047), 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) BK251296

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 Number00850034511047 UDI-DI Date24 Feb 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberBK251296 Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA premarket submission BK251296 Active
  • FDA GUDID UDI-DI 00850034511047 listed 24 Feb 2026 Listed

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Puregraft SYNC
Generic name
Autologous adipose tissue noninvasive processing set
Model / reference
PURE/SYNC
Primary DI / UDI-DI
00850034511047
FDA product code
QKL
GMDN term
Autologous adipose tissue noninvasive processing set
Device class
Class II
Regulation number
878.5040
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code QKL (Lipoaspirate Washing System For Aesthetic Body Contouring).

Other devices from Bimini Technologies LLC

See all devices from Bimini Technologies LLC →

Properties

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