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FDA 510(k)

QUILL SYNTHETIC ABSORBABLE BARBED SUTURE

K-Number: K042075 · 2004-10-26

ApplicantQuill Medical, Inc.
Decision Date2004-10-26
Product CodeNEW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

QUILL SYNTHETIC ABSORBABLE BARBED SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is Quill Medical, Inc.. It received FDA 510(k) clearance on 2004-10-26 under 510(k) number K042075. 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 SYNTHETIC ABSORBABLE BARBED SUTURE?

QUILL SYNTHETIC ABSORBABLE BARBED SUTURE is a medical device that received FDA 510(k) clearance on 2004-10-26. The listed applicant is Quill Medical, Inc.. The 510(k) number is K042075.

When did QUILL SYNTHETIC ABSORBABLE BARBED SUTURE receive FDA 510(k) clearance?

QUILL SYNTHETIC ABSORBABLE BARBED SUTURE received FDA 510(k) clearance on 2004-10-26, under 510(k) number K042075.

Who is the listed applicant for QUILL SYNTHETIC ABSORBABLE BARBED SUTURE?

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

What is the FDA product code for QUILL SYNTHETIC ABSORBABLE BARBED SUTURE?

The FDA product code for QUILL SYNTHETIC ABSORBABLE BARBED SUTURE 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.

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Other records listing Quill Medical, Inc. 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.

K052900QUILL NONABSORBABLE NYLON BARBED SUTUREK052373QUILL NONABSORBABLE POLYPROPYLENE BARBED SUTUREK051609QUILL SYNTHETIC ABSORBABLE BARBED SUTURE

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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