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Thoraguard System

by Centese, Inc.

510(k) K181667

Thoraguard System is a Class II device made by Centese, Inc., cleared under FDA 510(k) K181667 on 29 Nov 2018, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK181667 Date29 Nov 2018ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
BTA
Device class
Class II
Regulation
21 CFR Part 878.4780
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K181667

2 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K181667
UDI-DISize and differences
Thoraguard FGN-1387
Centese, Inc.
TGCM1000 / FGN-138700860000436427
Single use: no
On the market
Thoraguard FGS-1125
Centese, Inc.
TGDK110012 / FGS-112500860000436410
Single use: yes
On the market

Similar devices

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

Other devices from Centese, Inc.