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FDA 510(k)

MOUNTABLE ENDOSCOPIC BLADE

K-Number: K080133 · 2008-03-13

ApplicantA.M. Surgical, Inc.
Decision Date2008-03-13
Product CodeEMF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MOUNTABLE ENDOSCOPIC BLADE 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 2008-03-13 under 510(k) number K080133. 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 BLADE?

MOUNTABLE ENDOSCOPIC BLADE is a medical device that received FDA 510(k) clearance on 2008-03-13. The listed applicant is A.M. Surgical, Inc.. The 510(k) number is K080133.

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

MOUNTABLE ENDOSCOPIC BLADE received FDA 510(k) clearance on 2008-03-13, under 510(k) number K080133.

Who is the listed applicant for MOUNTABLE ENDOSCOPIC BLADE?

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 BLADE?

The FDA product code for MOUNTABLE ENDOSCOPIC BLADE 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.

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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 DeviceK042458A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEMK982142MOUNTABLE ENDOSCOPIC KNIFE

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.

K982142MOUNTABLE ENDOSCOPIC KNIFEA.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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