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FDA 510(k)

StitchKit

K-Number: K191317 · 2019-07-12

ApplicantOrigami Surgical
Decision Date2019-07-12
Product CodeNBY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

StitchKit is a medical device manufactured by Origami Surgical. It received FDA 510(k) clearance on 2019-07-12 under approval 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. It is manufactured by Origami Surgical. The 510(k) number is K191317.

When was StitchKit approved by the FDA?

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

What company makes StitchKit?

StitchKit is manufactured by Origami Surgical.

What is the FDA product code for StitchKit?

The FDA product code for StitchKit is NBY.

Other Devices by Origami Surgical

K202950StitchKit COMBO

Related Devices (Code: NBY)

K160744LOOK PTFE SutureSurgical Specialties Corporation K170842WEGO-PTFEFoosin Medical Supplies Inc., Ltd. K163049GOLNIT Non-Absorbable PTFE Surgical SutureAntarma Dba Golnit Sutures K163639LS-5 ePTFE SutureLsi Solutions K181578DemeTECH PTFE Nonabsorbable Surgical SutureDemetech Corporation K180630PTFE SURGICAL SUTUREOmnia Spa

Official Source

View on FDA Database →

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

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