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FDA 510(k)

TGS Guidewire and updated Scopis Software

K-Number: K193118 · 2020-02-21

ApplicantStryker Ent
Decision Date2020-02-21
Product CodePGW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TGS Guidewire and updated Scopis Software is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Ent. It received FDA 510(k) clearance on 2020-02-21 under 510(k) number K193118. The device is classified under product code PGW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TGS Guidewire and updated Scopis Software?

TGS Guidewire and updated Scopis Software is a medical device that received FDA 510(k) clearance on 2020-02-21. The listed applicant is Stryker Ent. The 510(k) number is K193118.

When did TGS Guidewire and updated Scopis Software receive FDA 510(k) clearance?

TGS Guidewire and updated Scopis Software received FDA 510(k) clearance on 2020-02-21, under 510(k) number K193118.

Who is the listed applicant for TGS Guidewire and updated Scopis Software?

The FDA 510(k) record lists Stryker Ent as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TGS Guidewire and updated Scopis Software?

The FDA product code for TGS Guidewire and updated Scopis Software is PGW.

Other records listing Stryker Ent as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: PGW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261540Cube 4D Navigation System, VirtuEye ProFiagon GmbHK253395Stealth AXiS™ ENT clinical applicationMedtronic Navigation, Inc.K243053Navient Image Guided Navigation System (ENT) (955-NC-NC)ClaronavK231862TruDi® Navigation System V3 (FG-2000-00)Acclarent, Inc.K223734ENT EMBrainlab AGK221037TruDi Shaver BladeAcclarent, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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