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FDA 510(k)

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

K-Number: K173874 · 2018-05-04

ApplicantOrigami Surgical, LLC
Decision Date2018-05-04
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Origami Surgical, LLC. The 510(k) number is K173874.

When was StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO approved by the FDA?

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

What company makes StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO?

StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO is manufactured by Origami Surgical, LLC.

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.

Related Devices (Code: GAM)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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