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FDA 510(k)

SURGIDEK

K-Number: K943216 · 1994-12-05

ApplicantSutures , Ltd.
Decision Date1994-12-05
Product CodeGAR
Advisory CommitteeSU
DecisionSubstantially Equivalent for Some Indications

Device Summary

SURGIDEK is the device name listed in this FDA 510(k) record. The listed applicant is Sutures , Ltd.. It received FDA 510(k) clearance on 1994-12-05 under 510(k) number K943216. The device is classified under product code GAR. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the SURGIDEK?

SURGIDEK is a medical device that received FDA 510(k) clearance on 1994-12-05. The listed applicant is Sutures , Ltd.. The 510(k) number is K943216.

When did SURGIDEK receive FDA 510(k) clearance?

SURGIDEK received FDA 510(k) clearance on 1994-12-05, under 510(k) number K943216.

Who is the listed applicant for SURGIDEK?

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

What is the FDA product code for SURGIDEK?

The FDA product code for SURGIDEK 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 Sutures , Ltd. 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.

K990432SURGISORBK953609PRODEKK943223SURGIDEK BK943217PLAIN CATGUTK943218CHROMIC CATGUTK943220SUTULENE

View all 11 devices →

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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