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 a medical device manufactured by Stryker Ent. It received FDA 510(k) clearance on 2020-02-21 under approval 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. It is manufactured by Stryker Ent. The 510(k) number is K193118.
When was TGS Guidewire and updated Scopis Software approved by the FDA?
TGS Guidewire and updated Scopis Software received FDA 510(k) clearance on 2020-02-21, under approval number K193118.
What company makes TGS Guidewire and updated Scopis Software?
TGS Guidewire and updated Scopis Software is manufactured by Stryker Ent.
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.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.