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L’disq® PD01

by CG MedTech Co., Ltd.

L’disq® PD01 is a Class II device made by CG MedTech Co., Ltd., cleared under FDA 510(k) K132797 on 30 Jul 2014 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 08800015900010), active as of 23 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 23 Oct 2026

Documents

510(k) K132797

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 Number08800015900010 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK132797 Date30 Jul 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K132797 decided 30 Jul 2014 Active
  • FDA GUDID UDI-DI 08800015900010 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K132797
  2. Listed FDA GUDID 08800015900010

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
L’disq®
Generic name
Electrosurgical return electrode, single-use, sterile
Model / reference
PD01
Primary DI / UDI-DI
08800015900010
510(k) Number
FDA product code
GEI
GMDN term
Electrosurgical return electrode, single-use, sterile
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution

Related devices

Category: Electrosurgical return electrode, single-use, sterile

Cleared under the same submission (K132797)

and 3 more cleared under K132797

Similar devices

Other devices filed under FDA product code GEI (ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES).

Other devices from CG MedTech Co., Ltd.

See all devices from CG MedTech Co., Ltd. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Serial number
Other properties (10, all answered No)