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FDA 510(k)

Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture,

K-Number: K160705 · 2016-11-23

ApplicantY. Jacobs Medical, Inc.
Decision Date2016-11-23
Product CodeNEW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture, is the device name listed in this FDA 510(k) record. The listed applicant is Y. Jacobs Medical, Inc.. It received FDA 510(k) clearance on 2016-11-23 under 510(k) number K160705. 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 Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture,?

Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture, is a medical device that received FDA 510(k) clearance on 2016-11-23. The listed applicant is Y. Jacobs Medical, Inc.. The 510(k) number is K160705.

When did Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture, receive FDA 510(k) clearance?

Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture, received FDA 510(k) clearance on 2016-11-23, under 510(k) number K160705.

Who is the listed applicant for Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture,?

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

What is the FDA product code for Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture,?

The FDA product code for Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture, is NEW.

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.

K261988Monodek™ (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.K251414Miracu™ Polydioxanone (PDO) Suture and Needle (MONO)Feeltech Co., Ltd.K250107V-soft Line™ Barbed Surgical Suture (Various)Feeltech Co., Ltd.

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.

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