TGS Guidewire and updated Scopis Software
FDA 510(k) K193118 · Stryker Ent
510(k) numberK193118
Submission
- Device name
- TGS Guidewire and updated Scopis Software
- Applicant
- Stryker Ent
Plymouth, MN, US - Received
- November 12, 2019
- Decision date
- February 21, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PGW – Ear, Nose, And Throat Stereotaxic Instrument
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.4560
- Specialty
- Neurology
Intended as an aid for precisely locating a surgical instrument within anatomical structures in either open or percutaneous procedures for any medical condition in which a reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT- or MR-based model or digitized landmarks of the anatomy.
Other 510(k)s with product code PGW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262235 | ApexCut Blade with Automated EM Tracking (187BL4012EM);ApexCut Blade with Automated…PGW · Traditional | Medtronic Xomed, Inc. | 09/04/2026SE |
| K261540 | Cube 4D Navigation System, VirtuEye ProPGW · Special | Fiagon GmbH | 06/02/2026SE |
| K253395 | Stealth AXiS ENT clinical applicationPGW · Traditional | Medtronic Navigation, Inc. | 03/16/2026SE |
| K243053 | Navient Image Guided Navigation System (ENT) (955-NC-NC)PGW · Traditional | Claronav | 06/20/2025SE |
| K231862 | TruDi® Navigation System V3 (FG-2000-00)PGW · Special | Acclarent, Inc. | 07/21/2023SE |
| K223734 | ENT EmPGW · Traditional | Brainlab AG | 04/27/2023SE |
| K221037 | TruDi Shaver BladePGW · Traditional | Acclarent, Inc. | 07/20/2022SE |
| K221098 | Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software…PGW · Traditional | Stryker Corporation | 07/12/2022SE |
| K211291 | Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4DPGW · Traditional | Fiagon GmbH | 07/19/2021SE |
| K202609 | Instrument Clamps ElectromagneticPGW · Special | Stryker Corporation | 10/09/2020SE |
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Questions and answers
When was TGS Guidewire and updated Scopis Software cleared by the FDA?
TGS Guidewire and updated Scopis Software (K193118) received a 510(k) decision of Substantially Equivalent on February 21, 2020, 101 days after the submission was received.
What is the product code of K193118?
The FDA product code is PGW – Ear, Nose, And Throat Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.