FDA 510(k)

Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar

Numéro K : K223593 · 2023-03-22

Date de décision2023-03-22

Code produitGCJ

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar is the device name listed in this FDA 510(k) record. The listed applicant is Taiwan Surgical Corporation. It received FDA 510(k) clearance on 2023-03-22 under 510(k) number K223593. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar?

Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar is a medical device that received FDA 510(k) clearance on 2023-03-22. The listed applicant is Taiwan Surgical Corporation. The 510(k) number is K223593.

When did Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar receive FDA 510(k) clearance?

Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar received FDA 510(k) clearance on 2023-03-22, under 510(k) number K223593.

Who is the listed applicant for Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar?

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

What is the FDA product code for Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar?

The FDA product code for Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar is GCJ.

Essais cliniques associés

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Source officielle

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