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Lithoclast B

by E.M.S. Electro Medical Systems S.A. 10 variants

Lithoclast B (FR-084) is a Class II device made by E.M.S. Electro Medical Systems S.A., cleared under FDA 510(k) K012445 on 24 Aug 2001 and listed in FDA GUDID since 17 Sep 2021 (UDI-DI 07613353001964), active as of 23 Oct 2026. 3 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

3 closed

Documents

510(k) K012445

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 Number07613353001964 UDI-DI Date17 Sep 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK012445 Date24 Aug 2001DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K012445 decided 24 Aug 2001 Active
  • FDA GUDID UDI-DI 07613353001964 listed 17 Sep 2021 Listed

Recalls

3 recalls · FDA

    • Terminated Z-0175-2010 FDA Unclassified (pre-2012) initiated 17 Sep 2009

    The label incorrectly reads "compatible with 330mm ultrasound probes (Ref 840-714 and 840-715)" instead of bearing the correct statement "compatible with 403mm ultrasound probes (Ref 840-716 and 840-7170."

    • Terminated Z-0684-2007 FDA Unclassified (pre-2012) initiated 16 Mar 2005

    Handpiece may become dislodged causing cable damage and possible electric shock.

    • Terminated Z-0078-04 FDA Unclassified (pre-2012) initiated 3 Oct 2003

    Failure of foot pedal to activate device

Timeline

5 dated events

  1. Cleared FDA 510(k) K012445
  2. Recall initiated FDA recalls Z-0078-04
  3. Recall initiated FDA recalls Z-0684-2007
  4. Recall initiated FDA recalls Z-0175-2010
  5. Listed FDA GUDID 07613353001964

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Lithoclast
Generic name
Ultrasonic lithotripsy system probe, reusable
Model / Ref / Catalog
B, FR-084
Primary DI / UDI-DI
07613353001964
510(k) Number
FDA product code
FFK
GMDN term
Ultrasonic lithotripsy system probe, reusable
Device class
Class II
Regulation number
876.4480
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Ultrasonic lithotripsy system probe, reusable

Cleared under the same submission (K012445)

and 8 more cleared under K012445

Other devices from Electro Medical Systems (Ems Sa)

See all devices from Electro Medical Systems (Ems Sa) →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)