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FDA 510(k)

SERRALGUT

K-Number: K020597 · 2002-08-14

ApplicantSerral, S.A. DE C.V.
Decision Date2002-08-14
Product CodeGAL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SERRALGUT 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 2002-08-14 under 510(k) number K020597. The device is classified under product code GAL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERRALGUT?

SERRALGUT is a medical device that received FDA 510(k) clearance on 2002-08-14. The listed applicant is Serral, S.A. DE C.V.. The 510(k) number is K020597.

When did SERRALGUT receive FDA 510(k) clearance?

SERRALGUT received FDA 510(k) clearance on 2002-08-14, under 510(k) number K020597.

Who is the listed applicant for SERRALGUT?

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 SERRALGUT?

The FDA product code for SERRALGUT is GAL.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K033762SERRALAPGK020902SERRALESTERK020901SERRALSILKK020146SERRALNYLK020265SERRALENE, MODEL CATALOG NO 1S

Related Devices (Code: GAL)

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.

K072930DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUTDemetech Corp.K042287UNIPLAIN & UNICHROMUnited Medical Industries Co. , Ltd.K042897AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGEEthicon Endo-Surgery, Inc.K030227SUTURTEK FASTCLOSE SUTURING DEVICESuturtek IncorporatedK021043GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMICGramsmed, LLCK011105SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICEQrc Consulting

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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