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FDA 510(k)

M.E.R. SURGICAL CO. OMNI INSTRUMENT SYSTEM

K-Number: K944309 · 1995-04-03

ApplicantM.E.R. Surgical Co.
Decision Date1995-04-03
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

M.E.R. SURGICAL CO. OMNI INSTRUMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is M.E.R. Surgical Co.. It received FDA 510(k) clearance on 1995-04-03 under 510(k) number K944309. 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 M.E.R. SURGICAL CO. OMNI INSTRUMENT SYSTEM?

M.E.R. SURGICAL CO. OMNI INSTRUMENT SYSTEM is a medical device that received FDA 510(k) clearance on 1995-04-03. The listed applicant is M.E.R. Surgical Co.. The 510(k) number is K944309.

When did M.E.R. SURGICAL CO. OMNI INSTRUMENT SYSTEM receive FDA 510(k) clearance?

M.E.R. SURGICAL CO. OMNI INSTRUMENT SYSTEM received FDA 510(k) clearance on 1995-04-03, under 510(k) number K944309.

Who is the listed applicant for M.E.R. SURGICAL CO. OMNI INSTRUMENT SYSTEM?

The FDA 510(k) record lists M.E.R. Surgical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for M.E.R. SURGICAL CO. OMNI INSTRUMENT SYSTEM?

The FDA product code for M.E.R. SURGICAL CO. OMNI INSTRUMENT SYSTEM 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 M.E.R. Surgical Co. 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.

K951424M. E. R. SURGICAL CO. OMIN INSTRUMENT SYSTEM

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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