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FDA 510(k)

StitchKit COMBO

K-Number: K202950 · 2021-02-23

ApplicantOrigami Surgical
Decision Date2021-02-23
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

StitchKit COMBO is the device name listed in this FDA 510(k) record. The listed applicant is Origami Surgical. It received FDA 510(k) clearance on 2021-02-23 under 510(k) number K202950. 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 COMBO?

StitchKit COMBO is a medical device that received FDA 510(k) clearance on 2021-02-23. The listed applicant is Origami Surgical. The 510(k) number is K202950.

When did StitchKit COMBO receive FDA 510(k) clearance?

StitchKit COMBO received FDA 510(k) clearance on 2021-02-23, under 510(k) number K202950.

Who is the listed applicant for StitchKit COMBO?

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 COMBO?

The FDA product code for StitchKit COMBO is GAM.

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.

K221527StitchKitK211792StitchKitK191317StitchKitK173874StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO

Related Devices (Code: GAM)

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.

K253394Coated VICRYL™ (Polyglactin 910) Plus Antibacterial SutureETHICON, Inc.K253530Trexon™ Monofilament Synthetic Absorbable SutureMedtronicK253852MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical SutureETHICON, Inc.K252743STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control DeviceETHICON, Inc.K253620TroClose 1200Gordian Surgical, Ltd.K252820PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus)Internacional Farmacéutica S.A DE C.V

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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