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Cathay CP1001

by Cathay Manufacturing Corp.

Cathay CP1001 is a Class II device made by Cathay Manufacturing Corp., cleared under FDA 510(k) K170369 on 19 Jul 2018 and listed in FDA GUDID since 8 Oct 2023 (UDI-DI 06959006302981), 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) K170369

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 Number06959006302981 UDI-DI Date8 Oct 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK170369 Date19 Jul 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K170369 decided 19 Jul 2018 Active
  • FDA GUDID UDI-DI 06959006302981 listed 8 Oct 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K170369
  2. Listed FDA GUDID 06959006302981

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Cathay
Generic name
Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
Model / reference
CP1001
Primary DI / UDI-DI
06959006302981
510(k) Number
FDA product code
GEI
GMDN term
Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Open-surgery electrosurgical handpiece/electrode, monopolar, single-use

Cleared under the same submission (K170369)

Similar devices in this category

Other devices filed under Open-surgery electrosurgical handpiece/electrode, monopolar, single-use.

Other devices from Cathay Manfacturing Corp.

See all devices from Cathay Manfacturing Corp. →

Properties

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