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FDA 510(k)

VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED

K-Number: K123034 · 2013-05-28

ApplicantUnilene Sac
Decision Date2013-05-28
Product CodeGAR
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED is the device name listed in this FDA 510(k) record. The listed applicant is Unilene Sac. It received FDA 510(k) clearance on 2013-05-28 under 510(k) number K123034. The device is classified under product code GAR. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED?

VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED is a medical device that received FDA 510(k) clearance on 2013-05-28. The listed applicant is Unilene Sac. The 510(k) number is K123034.

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

VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED received FDA 510(k) clearance on 2013-05-28, under 510(k) number K123034.

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

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 SUTUMED?

The FDA product code for VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED is GAR.

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.

K100780VITAL SUTURES, SUTUREX, CIRUGIA PERUANA

Related Devices (Code: GAR)

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.

K261484Tissue Approximation SystemTas Medical, Inc.K220980Tissue Approximation System (TAS)Tas Medical, Inc.K212888Golnit Nylon Monofilament SutureAntarma, LLC Dba Golnit SuturesK212603Non Absorbable Surgical Nylon SutureShandong Haidike Medical Product Co., Ltd.K192420Crownjun Nylon SutureKono Seisakusho Co., Ltd.K161633REXLON, REXSILSm Eng 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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