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FDA 510(k)

QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIXANONE)

K-Number: K120827 · 2012-07-13

ApplicantAngiotech
Decision Date2012-07-13
Product CodeNEW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIXANONE) is the device name listed in this FDA 510(k) record. The listed applicant is Angiotech. It received FDA 510(k) clearance on 2012-07-13 under 510(k) number K120827. The device is classified under product code NEW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIXANONE)?

QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIXANONE) is a medical device that received FDA 510(k) clearance on 2012-07-13. The listed applicant is Angiotech. The 510(k) number is K120827.

When did QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIXANONE) receive FDA 510(k) clearance?

QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIXANONE) received FDA 510(k) clearance on 2012-07-13, under 510(k) number K120827.

Who is the listed applicant for QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIXANONE)?

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 PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIXANONE)?

The FDA product code for QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIXANONE) is NEW.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K113744QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIOXANONE)K113800QUILL QUADRAHELIX TISSUE-CLOSURE DEVICEK073672SKATER BILIARY CATHETERK070610SKATER BILIARY CATHETER

Related Devices (Code: NEW)

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.

K254238MINT MONO SuturesHans Biomed CorporationK253879MONOFIX PDOSamyang Holdings CorporationK261988Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical SutureTeleflex Medical, LLCK252171Barbed PDO SutureSutura Medical Technology, Inc.K252047STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control DevicesETHICON, Inc.K243897PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical SutureETHICON, Inc.

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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