FDA 510(k)

MicroSTAAR Injector System Cartridges

Numéro K : K172375 · 2017-09-06

Date de décision2017-09-06

Code produitMSS

Comité consultatifOP

DécisionSubstantially Equivalent

Résumé du dispositif

MicroSTAAR Injector System Cartridges is the device name listed in this FDA 510(k) record. The listed applicant is STAAR Surgical Company. It received FDA 510(k) clearance on 2017-09-06 under 510(k) number K172375. The device is classified under product code MSS. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the MicroSTAAR Injector System Cartridges?

MicroSTAAR Injector System Cartridges is a medical device that received FDA 510(k) clearance on 2017-09-06. The listed applicant is STAAR Surgical Company. The 510(k) number is K172375.

When did MicroSTAAR Injector System Cartridges receive FDA 510(k) clearance?

MicroSTAAR Injector System Cartridges received FDA 510(k) clearance on 2017-09-06, under 510(k) number K172375.

Who is the listed applicant for MicroSTAAR Injector System Cartridges?

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

What is the FDA product code for MicroSTAAR Injector System Cartridges?

The FDA product code for MicroSTAAR Injector System Cartridges is MSS.

Essais cliniques associés

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Dispositifs connexes (Code : MSS)

K261174RxSight® Insertion DeviceRxsight, Inc.K252540ACCUJECT Ensemble d'injecteurs 2.1-1P (LP604590)Medicel AG K242389EyeGility™ Inserter for Preloaded enVista IOLsBausch & Lomb, Incorporated K231106Accuject Injecteur de Refraction AR2900Medicel AG K231838RxSight® Insertion Device (63002)Rxsight, Inc.K231466RxSight Insertion DeviceRxsight, Inc.

Source officielle

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