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FDA 510(k)

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

K-Number: K951424 · 1995-05-09

ApplicantM.E.R. Surgical Co.
Decision Date1995-05-09
Product CodeEOX
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

M. E. R. SURGICAL CO. OMIN 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 1995-05-09 under 510(k) number K951424. The device is classified under product code EOX. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the M. E. R. SURGICAL CO. OMIN INSTRUMENT SYSTEM?

M. E. R. SURGICAL CO. OMIN INSTRUMENT SYSTEM is a medical device that received FDA 510(k) clearance on 1995-05-09. The listed applicant is M.E.R. Surgical Co.. The 510(k) number is K951424.

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

M. E. R. SURGICAL CO. OMIN INSTRUMENT SYSTEM received FDA 510(k) clearance on 1995-05-09, under 510(k) number K951424.

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

The FDA product code for M. E. R. SURGICAL CO. OMIN INSTRUMENT SYSTEM is EOX.

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.

K944309M.E.R. SURGICAL CO. OMNI INSTRUMENT SYSTEM

Related Devices (Code: EOX)

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.

K233142EndoSign® Cell collection device (ES-CYT-102)Cyted LimitedK230339EsoCheck Cell Collection DeviceLucid Diagnostics, Inc.K223072PENTAX Medical Video Esophagoscope EE17-J10Pentax of America, Inc.K222366EsoCheck Cell Collection DeviceLucid Diagnostics, Inc.K203450EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)Capnostics, LLCK210137EsoCheck Cell Collection DeviceLucid Diagnostics, 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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