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FDA 510(k)

SERRALENE, MODEL CATALOG NO 1S

K-Number: K020265 · 2002-03-08

ApplicantSerral, S.A. DE C.V.
Decision Date2002-03-08
Product CodeGAW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SERRALENE, MODEL CATALOG NO 1S is the device name listed in this FDA 510(k) record. The listed applicant is Serral, S.A. DE C.V.. It received FDA 510(k) clearance on 2002-03-08 under 510(k) number K020265. The device is classified under product code GAW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERRALENE, MODEL CATALOG NO 1S?

SERRALENE, MODEL CATALOG NO 1S is a medical device that received FDA 510(k) clearance on 2002-03-08. The listed applicant is Serral, S.A. DE C.V.. The 510(k) number is K020265.

When did SERRALENE, MODEL CATALOG NO 1S receive FDA 510(k) clearance?

SERRALENE, MODEL CATALOG NO 1S received FDA 510(k) clearance on 2002-03-08, under 510(k) number K020265.

Who is the listed applicant for SERRALENE, MODEL CATALOG NO 1S?

The FDA 510(k) record lists Serral, S.A. DE C.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SERRALENE, MODEL CATALOG NO 1S?

The FDA product code for SERRALENE, MODEL CATALOG NO 1S is GAW.

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Other records listing Serral, S.A. DE C.V. 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.

K033762SERRALAPGK020597SERRALGUTK020902SERRALESTERK020901SERRALSILKK020146SERRALNYL

Related Devices (Code: GAW)

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.

K253572STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control DeviceETHICON, Inc.K233355Cypris eXact Suturing SystemCypris MedicalK230746Non absorbable Surgical Polypropylene SutureShandong Haidike Medical Products Co., Ltd.K221280VessealLydus Medical , Ltd.K211178DURAMESH Mesh SutureMsiK192953APTOS Threads – Polypropylene Surgical SuturesAptos, LLC

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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