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FDA 510(k)

MOUNTABLE ENDOSCOPIC KNIFE

K-Number: K982142 · 1998-12-30

ApplicantA.M. Surgical, Inc.
Decision Date1998-12-30
Product CodeEMF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MOUNTABLE ENDOSCOPIC KNIFE is the device name listed in this FDA 510(k) record. The listed applicant is A.M. Surgical, Inc.. It received FDA 510(k) clearance on 1998-12-30 under 510(k) number K982142. The device is classified under product code EMF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOUNTABLE ENDOSCOPIC KNIFE?

MOUNTABLE ENDOSCOPIC KNIFE is a medical device that received FDA 510(k) clearance on 1998-12-30. The listed applicant is A.M. Surgical, Inc.. The 510(k) number is K982142.

When did MOUNTABLE ENDOSCOPIC KNIFE receive FDA 510(k) clearance?

MOUNTABLE ENDOSCOPIC KNIFE received FDA 510(k) clearance on 1998-12-30, under 510(k) number K982142.

Who is the listed applicant for MOUNTABLE ENDOSCOPIC KNIFE?

The FDA 510(k) record lists A.M. Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MOUNTABLE ENDOSCOPIC KNIFE?

The FDA product code for MOUNTABLE ENDOSCOPIC KNIFE is EMF.

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 A.M. Surgical, Inc. 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.

K191771SECURE ScrewK191345Pegasus SystemK180087A.M. Surgical Intramedullary Fixation DeviceK080133MOUNTABLE ENDOSCOPIC BLADEK042458A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM

Related Devices (Code: EMF)

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.

K080133MOUNTABLE ENDOSCOPIC BLADEA.M. Surgical, Inc.K890217MICROSURGICAL KNIVESKinetic Medical ProductsK890214MICROSURGERY RAZOR BLADE HOLDERKinetic Medical ProductsK890215MICROSURGICAL SCARIFIERKinetic Medical ProductsK880094VAN-TEC ENDOPYELOTOMY KNIFEVan-Tec, Inc.K863752VALTRAC (BAR) REMOVER DEVICEDavis & Geck, 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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