Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SERRALNYL

K-Number: K020146 · 2002-04-15

ApplicantSerral, S.A. DE C.V.
Decision Date2002-04-15
Product CodeGAR
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SERRALNYL 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 2002-04-15 under 510(k) number K020146. 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 SERRALNYL?

SERRALNYL is a medical device that received FDA 510(k) clearance on 2002-04-15. The listed applicant is Serral, S.A. DE C.V.. The 510(k) number is K020146.

When did SERRALNYL receive FDA 510(k) clearance?

SERRALNYL received FDA 510(k) clearance on 2002-04-15, under 510(k) number K020146.

Who is the listed applicant for SERRALNYL?

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 SERRALNYL?

The FDA product code for SERRALNYL 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.

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.

K033762SERRALAPGK020597SERRALGUTK020902SERRALESTERK020901SERRALSILKK020265SERRALENE, MODEL CATALOG NO 1S

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.

↑