FDA 510(k)

QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN

K-Number: K130078 · 2013-02-28

ApplicantSurgical Specialties Corp. Dba Angiotech

Decision Date2013-02-28

Product CodeGAW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Specialties Corp. Dba Angiotech. It received FDA 510(k) clearance on 2013-02-28 under 510(k) number K130078. 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 POLYPROPYLENE KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN?

QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN is a medical device that received FDA 510(k) clearance on 2013-02-28. The listed applicant is Surgical Specialties Corp. Dba Angiotech. The 510(k) number is K130078.

When did QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN receive FDA 510(k) clearance?

QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN received FDA 510(k) clearance on 2013-02-28, under 510(k) number K130078.

Who is the listed applicant for QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN?

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

What is the FDA product code for QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN?

The FDA product code for QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN is GAW.

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Other records listing Surgical Specialties Corp. Dba Angiotech as applicant

K133420TRANQUILL BARBED DEVICE K131224SHARPOINT POLYPROPYLENE SURGICAL SUTURE, LOOK POLYPROPYLENE SURGICAL SUTURE, QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE K123877QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN K123836QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN K123409QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN K122898QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN

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Related Devices (Code: GAW)

K253572STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control DeviceETHICON, Inc.K233355Cypris eXact Suturing SystemCypris Medical K230746Non absorbable Surgical Polypropylene SutureShandong Haidike Medical Products Co., Ltd.K221280VessealLydus Medical , Ltd.K211178DURAMESH Mesh SutureMsi K192953APTOS Threads – Polypropylene Surgical SuturesAptos, LLC

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.