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LeadLoc Depth Stop 66-AC-DCS-00520

by Fhc, Inc.

LeadLoc Depth Stop 66-AC-DCS-00520 is a Class II device made by Fhc, Inc., cleared under FDA 510(k) K011992 on 14 Aug 2001 and listed in FDA GUDID since 17 Sep 2016 (UDI-DI 10873263005207), active as of 23 Oct 2026. 6 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

6 closed

Documents

510(k) K011992

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 Number10873263005207 UDI-DI Date17 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK011992 Date14 Aug 2001DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K011992 decided 14 Aug 2001 Active
  • FDA GUDID UDI-DI 10873263005207 listed 17 Sep 2016 Listed

Recalls

6 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-2359-2018 FDA Class II initiated 10 May 2018
    • Terminated Z-2353-2018 FDA Class II initiated 10 May 2018

    The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, and has resulted in the need to remove and replace the implanted lead intraoperative or in a follow-up procedure.

    • Terminated Z-0486-2009 FDA Unclassified (pre-2012) initiated 8 Oct 2008

    Measuring fixture is incorrectly graduated.

  • 2 recalls, same reason

    • Terminated Z-0180-06 FDA Unclassified (pre-2012) initiated 31 Oct 2005
    • Terminated Z-0179-06 FDA Unclassified (pre-2012) initiated 31 Oct 2005

    Power Assist microTargeting System may advance beyond intended target

    • Terminated Z-0895-05 FDA Unclassified (pre-2012) initiated 14 Mar 2005

    Potential for non-sterile pin to contaminate sterile field

Timeline

8 dated events

  1. Cleared FDA 510(k) K011992
  2. Recall initiated FDA recalls Z-0895-05
  3. Recall initiated FDA recalls Z-0180-06
  4. Recall initiated FDA recalls Z-0179-06
  5. Recall initiated FDA recalls Z-0486-2009
  6. Listed FDA GUDID 10873263005207
  7. Recall initiated FDA recalls Z-2359-2018
  8. Recall initiated FDA recalls Z-2353-2018

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
LeadLoc Depth Stop
Generic name
Neurosurgical micro targeting drive
Model / Ref / Catalog
66-AC-DCS-00520, 66-AC-DCS
Primary DI / UDI-DI
10873263005207
510(k) Number
FDA product code
HAW
GMDN term
Neurosurgical micro targeting drive
Device class
Class II
Regulation number
882.4560
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Neurosurgical micro targeting drive

Cleared under the same submission (K011992)

and 8 more cleared under K011992

Other devices from Fhc, Inc.

See all devices from Fhc, Inc. →

Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (10, all answered No)