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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 the device name listed in this FDA 510(k) record. The listed applicant is Origami Surgical, LLC. It received FDA 510(k) clearance on 2018-05-04 under 510(k) 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. The listed applicant is Origami Surgical, LLC. The 510(k) number is K173874.

When did StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO receive FDA 510(k) clearance?

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

Who is the listed applicant for StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO?

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

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.

Other records listing Origami Surgical, LLC 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.

K221527StitchKitK211792StitchKitK202950StitchKit COMBOK191317StitchKit

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

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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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