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Summit Medical FL3000-05

by Summit Medical, LLC

Summit Medical FL3000-05 is a Class II device made by Summit Medical, LLC, cleared under FDA 510(k) K092482 on 4 Dec 2009 (1 earlier submission) and listed in FDA GUDID since 12 Dec 2022 (UDI-DI 00385640061469), active as of 23 Oct 2026. 8 FDA recalls are linked to it.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

8 closed

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00385640061469 UDI-DI Date12 Dec 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK092482 Date4 Dec 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K092482 decided 4 Dec 2009 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00385640061469 listed 12 Dec 2022 Listed

Recalls

8 recalls · FDA

  • 5 recalls, same reason

    • Completed Z-1335-2019 FDA Class II initiated 2 Feb 2018
    • Completed Z-1330-2019 FDA Class II initiated 2 Feb 2018
    • Completed Z-1336-2019 FDA Class II initiated 2 Feb 2018
    • Completed Z-1331-2019 FDA Class II initiated 2 Feb 2018
    • Completed Z-1332-2019 FDA Class II initiated 2 Feb 2018

    The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch.

  • 2 recalls, same reason

    • Completed Z-1334-2019 FDA Class II initiated 2 Feb 2018
    • Completed Z-1333-2019 FDA Class II initiated 2 Feb 2018
    • Terminated Z-0170-2018 FDA Class II initiated 20 Oct 2017

    Potential breach of sterility of the packaging.

Timeline

11 dated events

  1. Cleared FDA 510(k) K092482
  2. Recall initiated FDA recalls Z-0170-2018
  3. Recall initiated FDA recalls Z-1335-2019
  4. Recall initiated FDA recalls Z-1330-2019
  5. Recall initiated FDA recalls Z-1336-2019
  6. Recall initiated FDA recalls Z-1331-2019
  7. Recall initiated FDA recalls Z-1332-2019
  8. Recall initiated FDA recalls Z-1334-2019
  9. Recall initiated FDA recalls Z-1333-2019
  10. Listed FDA GUDID 00385640061469

1 earlier event are in the sections above.

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Summit Medical
Generic name
Liposuction system
Model / reference
FL3000-05
Primary DI / UDI-DI
00385640061469
510(k) Number
FDA product code
MUU
GMDN term
Liposuction system
Device class
Class II
Regulation number
878.5040
GUDID distribution status
In Commercial Distribution

Related devices

Category: Liposuction system

Cleared under the same submission (K092284)

and 2 more cleared under K092284

Cleared under the same submission (K092482)

and 8 more cleared under K092482

Similar devices in this category

Other devices filed under Liposuction system.

Other devices from Summit Medical, LLC

See all devices from Summit Medical, LLC →

Properties

  • Single use
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)