Tgs Tgsgw
Tgs Tgsgw (8000-060-009) is a Class II device made by Stryker Corp., listed in FDA GUDID since 19 May 2020 (UDI-DI 00850002250220), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00850002250220 | Date19 May 2020 | StatusListed |
Official records
- AccessGUDID record 00850002250220
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Tgs
- Generic name
- Stereotactic surgery system probe, single-use
- Model / Ref / Catalog
- TGSGW, 8000-060-009
- Primary DI / UDI-DI
- 00850002250220
- FDA product code
- PGW
- GMDN term
- Stereotactic surgery system probe, single-use
- Device class
- Class II
- Regulation number
- 882.4560
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code PGW (Ear, Nose, And Throat Stereotaxic Instrument).
- TruDi Navigation System by Biosense Webster Inc
- TGS Guidewire and updated Scopis Software by Stryker Ent
- ApexCut ™ Blade with Automated EM Tracking (187BL4012EM) by Medtronic Xomed Inc
- TruDi Probe by ACCLARENT, INC.
- Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D by Fiagon GmbH
- Cube 4D Navigation System, VirtuEye Pro by Fiagon GmbH
- KARL STORZ NAV1 Electromagnetic Navigation System by Karl Storz Endoscopy-America, Inc.
- TGS Navigation 8000-010-003 by Stryker Leibinger
- Scopis Hybrid Navigation System EM by Scopis GmbH
- Acclarent ENT Navigation System by ACCLARENT, INC.