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FDA 510(k)

Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00)

Numéro K : K233653 · 2024-08-05

DemandeurPeregrine Surgical, LLC
Date de décision2024-08-05
Code produitMPA
Comité consultatifGU
DécisionSubstantially Equivalent

Résumé du dispositif

Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00) is the device name listed in this FDA 510(k) record. The listed applicant is Peregrine Surgical, LLC. It received FDA 510(k) clearance on 2024-08-05 under 510(k) number K233653. The device is classified under product code MPA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00)?

Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00) is a medical device that received FDA 510(k) clearance on 2024-08-05. The listed applicant is Peregrine Surgical, LLC. The 510(k) number is K233653.

When did Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00) receive FDA 510(k) clearance?

Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00) received FDA 510(k) clearance on 2024-08-05, under 510(k) number K233653.

Who is the listed applicant for Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00)?

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

What is the FDA product code for Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00)?

The FDA product code for Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00) is MPA.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

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Dispositifs connexes (Code : MPA)

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

K253468Nova Eye iTrack™ 250A Canaloplasty Microcatheter (iTrack™ 250A)Nova Eye, Inc.K242184Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256);Alcon Laboratories, Inc.K221872ITrack Advance Canaloplasty Microcatheter with Advanced Delivery SystemNova Eye Inc. (Business Name Nova Eye Medical)K202670Nam illumination probe with chopperOculight , Ltd.

Source officielle

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