FDA 510(k)

StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO

Numéro K : K173874 · 2018-05-04

Date de décision2018-05-04

Code produitGAM

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO is the device name listed in this FDA 510(k) record. The listed applicant is Origami Surgical, LLC. It received FDA 510(k) clearance on 2018-05-04 under 510(k) number K173874. The device is classified under product code GAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO?

StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO is a medical device that received FDA 510(k) clearance on 2018-05-04. The listed applicant is Origami Surgical, LLC. The 510(k) number is K173874.

When did StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO receive FDA 510(k) clearance?

StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO received FDA 510(k) clearance on 2018-05-04, under 510(k) number K173874.

Who is the listed applicant for StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO?

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

What is the FDA product code for StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO?

The FDA product code for StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO is GAM.

Essais cliniques associés

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Dispositifs connexes (Code : GAM)

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Source officielle

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