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LL100 Cryosurgical System

by Wallach Surgical Devices, Inc.

510(k) K803311

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK803311 Date4 Feb 1981ClearedStatusActive

Recalls

3 recalls · FDA

    • Terminated Z-1450-2015 FDA Class II initiated 9 Mar 2015

    Internal gas line may malfunction causing the line to burst under pressure.

  • 2 recalls, same reason

    • Terminated Z-1045-2007 FDA Unclassified (pre-2012) initiated 6 Jun 2007
    • Terminated Z-1046-2007 FDA Unclassified (pre-2012) initiated 6 Jun 2007

    The tip may separate from the probe.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GEH
Device Class
Class II
Regulation
21 CFR Part 878.4350
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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