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FDA 510(k)

QUILL QUADRAHELIX TISSUE-CLOSURE DEVICE

K-Number: K113800 · 2012-01-20

ApplicantAngiotech
Decision Date2012-01-20
Product CodeGAW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

QUILL QUADRAHELIX TISSUE-CLOSURE DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Angiotech. It received FDA 510(k) clearance on 2012-01-20 under 510(k) number K113800. The device is classified under product code GAW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUILL QUADRAHELIX TISSUE-CLOSURE DEVICE?

QUILL QUADRAHELIX TISSUE-CLOSURE DEVICE is a medical device that received FDA 510(k) clearance on 2012-01-20. The listed applicant is Angiotech. The 510(k) number is K113800.

When did QUILL QUADRAHELIX TISSUE-CLOSURE DEVICE receive FDA 510(k) clearance?

QUILL QUADRAHELIX TISSUE-CLOSURE DEVICE received FDA 510(k) clearance on 2012-01-20, under 510(k) number K113800.

Who is the listed applicant for QUILL QUADRAHELIX TISSUE-CLOSURE DEVICE?

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

What is the FDA product code for QUILL QUADRAHELIX TISSUE-CLOSURE DEVICE?

The FDA product code for QUILL QUADRAHELIX TISSUE-CLOSURE DEVICE is GAW.

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Other records listing Angiotech 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.

K120827QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIXANONE)K113744QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIOXANONE)K073672SKATER BILIARY CATHETERK070610SKATER BILIARY CATHETER

Related Devices (Code: GAW)

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.

K253572STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control DeviceETHICON, Inc.K233355Cypris eXact Suturing SystemCypris MedicalK230746Non absorbable Surgical Polypropylene SutureShandong Haidike Medical Products Co., Ltd.K221280VessealLydus Medical , Ltd.K211178DURAMESH Mesh SutureMsiK192953APTOS Threads – Polypropylene Surgical SuturesAptos, LLC

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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