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Licox® BC10

by GMS, Gesellschaft für medizinische Sondentechnik mbH

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

3 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10381780041283 UDI-DI Date1 Oct 2015ListedStatusListed GUDID: not in commercial distribution

Recalls

3 recalls · FDA

    • Terminated Z-0831-2015 FDA Class II initiated 7 Nov 2014

    Due to a complaint, it was determined that multiple lots of Licox catheters manufactured since October 29, 2013 contained a smart card which was programmed with an inaccurate lkN2 value.

    • Terminated Z-1518-2011 FDA Unclassified (pre-2012) initiated 17 Dec 2010

    Certain LICOX CMP Tissue Oxygen Monitors could allow for underestimation of temperature values.

    • Terminated Z-0622-05 FDA Unclassified (pre-2012) initiated 21 Jan 2005 on shared 510(k) K002765

    LICOX Model C8.B temperature probes manufactured by GMS mbH, an Integra company, may exhibit progen (endotoxin) levels above the FDA limit of 2.15 endotoxin units per device. Elevated endotoxin levels may result in an increased patient risk of fever.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Licox®
Generic Name
Electrical-only medical device connection cable, reusable
Model / Ref / Catalog
BC10
Primary DI / UDI-DI
10381780041283
510(k) Number
FDA Product Code
GWM
GMDN Term
Electrical-only medical device connection cable, reusable
Device Class
Class II
Regulation Number
882.1620
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K002765)

Show all (11)

Properties

  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Manufacturing Date

Other properties (10)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No