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Megabeam Endo-Ent Probe

FDA 510(k)

Class II (US FDA 510(k))

510(k) K952772

by Ceram Optec, Inc.

Identifiers

510(k) Number
K952772 FDA 510(k)
FDA Product Code
GEX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4810 FDA 510(k)
Regulation Number
878.4810 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Megabeam Endo-Ent Probe is a medical device designed for use in endoscopic ear, nose, and throat procedures. It functions as a specialized probe to facilitate surgical access and intervention within these anatomical areas.

This device is identified under FDA 510(k) clearance K952772. It is available in the 24Ga model ENT-24-HGM-S and is manufactured by Ceram Optec, Inc.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K952772 FDA 510(k) - MEGABEAM ENDO-ENT PROBE | Ceram Optec, Inc., Ceram Optec SIA ENT-24-HGM-S MegaBeam® Endo-ENT Probe - RevMed, MegaBeam® Endo-ENT Probe - BEUDAMED, MEGABEAM ENDO-ENT PROBE 510(k) K952772 - FDA.report, PDF K952772 MEGABEAM ENDO-ENT PROBE - 510kdatabase.net

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ceram Optec, Inc.

Sources (1)

  • FDA 510(k) K952772 24 fields · synced Sep 26, 2026