FDA 510(k)

StitchKit

K-Number: K191317 · 2019-07-12

Decision Date2019-07-12

Product CodeNBY

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

StitchKit is the device name listed in this FDA 510(k) record. The listed applicant is Origami Surgical. It received FDA 510(k) clearance on 2019-07-12 under 510(k) number K191317. The device is classified under product code NBY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the StitchKit?

StitchKit is a medical device that received FDA 510(k) clearance on 2019-07-12. The listed applicant is Origami Surgical. The 510(k) number is K191317.

When did StitchKit receive FDA 510(k) clearance?

StitchKit received FDA 510(k) clearance on 2019-07-12, under 510(k) number K191317.

Who is the listed applicant for StitchKit?

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

What is the FDA product code for StitchKit?

The FDA product code for StitchKit is NBY.

Other records listing Origami Surgical as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221527StitchKit K211792StitchKit K202950StitchKit COMBO K173874StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO

Related Devices (Code: NBY)

K231277TissueStatDurastat, LLC K192088GOLNIT Non-aborbable PTFE Surgical SutureAntarma, LLC Dba Golnit Sutures K180992BiotexPurgo Biologics, Inc.K181578DemeTECH PTFE Nonabsorbable Surgical SutureDemetech Corporation K180630PTFE SURGICAL SUTUREOmnia Spa K173922C-PTFETM Surgical SutureCp Medical, Inc.

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.