FDA 510(k)

MGB LAPALUX TELESCOPE

K-Number: K982013 · 1998-10-21

Decision Date1998-10-21

Product CodeGCJ

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

MGB LAPALUX TELESCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Mgb Endoskopische Gerate GmbH. It received FDA 510(k) clearance on 1998-10-21 under 510(k) number K982013. 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 MGB LAPALUX TELESCOPE?

MGB LAPALUX TELESCOPE is a medical device that received FDA 510(k) clearance on 1998-10-21. The listed applicant is Mgb Endoskopische Gerate GmbH. The 510(k) number is K982013.

When did MGB LAPALUX TELESCOPE receive FDA 510(k) clearance?

MGB LAPALUX TELESCOPE received FDA 510(k) clearance on 1998-10-21, under 510(k) number K982013.

Who is the listed applicant for MGB LAPALUX TELESCOPE?

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

What is the FDA product code for MGB LAPALUX TELESCOPE?

The FDA product code for MGB LAPALUX TELESCOPE 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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Related Devices (Code: GCJ)

K262397CuratOR EX2742Eizo Corporation K260884UNIDRIVE Select SystemKarl Storz SE & CO. KG K260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony Corporation K261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLC K253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical Impact K261614LED 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.