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Thoraguard FGN-1387

by Centese, Inc.

Thoraguard FGN-1387 (TGCM1000) is a Class II device made by Centese, Inc., cleared under FDA 510(k) K181667 on 29 Nov 2018 and listed in FDA GUDID since 7 Oct 2020 (UDI-DI 00860000436427), 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) K181667

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 Number00860000436427 UDI-DI Date7 Oct 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK181667 Date29 Nov 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K181667 decided 29 Nov 2018 Active
  • FDA GUDID UDI-DI 00860000436427 listed 7 Oct 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K181667
  2. Listed FDA GUDID 00860000436427

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Thoraguard
Generic name
Thoracic suction pump
Model / Ref / Catalog
FGN-1387, TGCM1000
Primary DI / UDI-DI
00860000436427
510(k) Number
FDA product code
BTA
GMDN term
Thoracic suction pump
Device class
Class II
Regulation number
878.4780
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Thoracic suction pump

Cleared under the same submission (K181667)

Similar devices

Other devices filed under FDA product code BTA (Pump, Portable, Aspiration (Manual Or Powered)).

Other devices from Centese, Inc.

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)