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FDA 510(k)

VITAL SUTURES, SUTUREX, CIRUGIA PERUANA

K-Number: K100780 · 2010-12-14

ApplicantUnilene Sac
Decision Date2010-12-14
Product CodeNEW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VITAL SUTURES, SUTUREX, CIRUGIA PERUANA is the device name listed in this FDA 510(k) record. The listed applicant is Unilene Sac. It received FDA 510(k) clearance on 2010-12-14 under 510(k) number K100780. 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 VITAL SUTURES, SUTUREX, CIRUGIA PERUANA?

VITAL SUTURES, SUTUREX, CIRUGIA PERUANA is a medical device that received FDA 510(k) clearance on 2010-12-14. The listed applicant is Unilene Sac. The 510(k) number is K100780.

When did VITAL SUTURES, SUTUREX, CIRUGIA PERUANA receive FDA 510(k) clearance?

VITAL SUTURES, SUTUREX, CIRUGIA PERUANA received FDA 510(k) clearance on 2010-12-14, under 510(k) number K100780.

Who is the listed applicant for VITAL SUTURES, SUTUREX, CIRUGIA PERUANA?

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

What is the FDA product code for VITAL SUTURES, SUTUREX, CIRUGIA PERUANA?

The FDA product code for VITAL SUTURES, SUTUREX, CIRUGIA PERUANA 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 Unilene Sac 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.

K123034VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED

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

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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