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FDA 510(k)

A-LAP SET (A-LAP, EZAXESS, TROCAR)

K-Number: K082291 · 2009-01-02

ApplicantEzsurgical
Decision Date2009-01-02
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

A-LAP SET (A-LAP, EZAXESS, TROCAR) is the device name listed in this FDA 510(k) record. The listed applicant is Ezsurgical. It received FDA 510(k) clearance on 2009-01-02 under 510(k) number K082291. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A-LAP SET (A-LAP, EZAXESS, TROCAR)?

A-LAP SET (A-LAP, EZAXESS, TROCAR) is a medical device that received FDA 510(k) clearance on 2009-01-02. The listed applicant is Ezsurgical. The 510(k) number is K082291.

When did A-LAP SET (A-LAP, EZAXESS, TROCAR) receive FDA 510(k) clearance?

A-LAP SET (A-LAP, EZAXESS, TROCAR) received FDA 510(k) clearance on 2009-01-02, under 510(k) number K082291.

Who is the listed applicant for A-LAP SET (A-LAP, EZAXESS, TROCAR)?

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

What is the FDA product code for A-LAP SET (A-LAP, EZAXESS, TROCAR)?

The FDA product code for A-LAP SET (A-LAP, EZAXESS, TROCAR) is GCJ.

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 Ezsurgical 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.

K071775DASH

Related Devices (Code: GCJ)

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.

K262397CuratOR EX2742Eizo CorporationK260884UNIDRIVE Select SystemKarl Storz SE & CO. KGK260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony CorporationK261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.Inc

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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