FDA 510(k)

StitchKit

K-Number: K211792 · 2021-07-16

Decision Date2021-07-16

Product CodeGAM

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

StitchKit is a medical device manufactured by Origami Surgical Inc .. It received FDA 510(k) clearance on 2021-07-16 under approval number K211792. 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?

StitchKit is a medical device that received FDA 510(k) clearance on 2021-07-16. It is manufactured by Origami Surgical Inc .. The 510(k) number is K211792.

When was StitchKit approved by the FDA?

StitchKit received FDA 510(k) clearance on 2021-07-16, under approval number K211792.

What company makes StitchKit?

StitchKit is manufactured by Origami Surgical Inc ..

What is the FDA product code for StitchKit?

The FDA product code for StitchKit is GAM.

Other Devices by Origami Surgical Inc .

K221527StitchKit

Related Devices (Code: GAM)

K160564TroClose1200Gordian Surgical, Ltd. K161726E-Pack Procedure KitETHICON, Inc. K153611Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable Suture Cartridges, ETHIBOND Polybutilate Coated Polyester Sterile Synthetic Non-Absorbable Suture Cartridges, PROXISURE Suturing DeviceEthicon, LLC K173043Holycon Synthetic Absorbable SuturesNantong Holycon Medical Devices Co., Ltd. K171001Monosyn Quick Synthetic Absorbable Surgical SutureAesculap, Inc. K170166CARESORB-Polyglactin 910 Surgical Suture, CARESORB-Polyglactin 910 (fast absorbing) Surgical SutureCpt Sutures Co., Ltd.

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.