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LiDCO Li11190

by Lidco Limited

LiDCO Li11190 is a Class II device made by Lidco Limited, cleared under FDA 510(k) K131048 on 28 Aug 2013 and listed in FDA GUDID since 27 Mar 2018 (UDI-DI 05060110522903), active as of 22 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K131048

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05060110522903 UDI-DI Date27 Mar 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK131048 Date28 Aug 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K131048 decided 28 Aug 2013 Active
  • FDA GUDID UDI-DI 05060110522903 listed 27 Mar 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K131048
  2. Listed FDA GUDID 05060110522903

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
LiDCO
Generic name
General-body orifice lubricant, non-sterile
Model / Ref / Catalog
Li11190
Primary DI / UDI-DI
05060110522903
510(k) Number
FDA product code
DXG
GMDN term
General-body orifice lubricant, non-sterile
Device class
Class II
Regulation number
870.1435
GUDID distribution status
In Commercial Distribution

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See all devices from Lidco Limited →

Properties

  • Prescription use
Other properties (14, all answered No)