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FDA 510(k)

ARTELON SURGICAL SUTURE

K-Number: K052482 · 2005-10-17

ApplicantArtimplant AB
Decision Date2005-10-17
Product CodeGAR
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ARTELON SURGICAL SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is Artimplant AB. It received FDA 510(k) clearance on 2005-10-17 under 510(k) number K052482. 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 ARTELON SURGICAL SUTURE?

ARTELON SURGICAL SUTURE is a medical device that received FDA 510(k) clearance on 2005-10-17. The listed applicant is Artimplant AB. The 510(k) number is K052482.

When did ARTELON SURGICAL SUTURE receive FDA 510(k) clearance?

ARTELON SURGICAL SUTURE received FDA 510(k) clearance on 2005-10-17, under 510(k) number K052482.

Who is the listed applicant for ARTELON SURGICAL SUTURE?

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

What is the FDA product code for ARTELON SURGICAL SUTURE?

The FDA product code for ARTELON SURGICAL SUTURE is GAR.

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Other records listing Artimplant AB 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.

K071887SPORTMESH OR ARTELON TISSUE REINFORCEMENTK061956ARTELON STT SPACERK061954ARTELON CMC SPACER ARTHROK052830SPORTMESHK040070ARTELON SPACER CMC-1K032160ARTELON SURGICAL SUTURE

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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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