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360 Gas Assisted Endoscopic Applicator

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K122526

by Micromedics, Inc.

Identifiers

510(k) Number
K122526 FDA 510(k)
FDA Product Code
GCJ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.1500 FDA 510(k)
Regulation Number
876.1500 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The 360 Gas Assisted Endoscopic Applicator is a medical device classified as an endoscopic applicator, designed to assist in the delivery of therapeutic agents or substances during endoscopic procedures. It utilises gas assistance to enhance precision and control during application within the gastrointestinal or urinary tract, facilitating procedures such as biopsies, ablation, or drug delivery.

This device is supplied sterile and intended for single-use, ensuring compliance with endoscopic standards. It is regulated under FDA 510(k) clearance (K122526) and meets the Medical Device Directive (MDD) requirements. The applicator is compatible with standard endoscopic systems and is available in a configuration tailored for endoscopic procedures, with no MRI safety restrictions noted. Storage and handling follow standard sterile medical device protocols.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Micromedics, Inc.

Sources (2)

  • FDA 510(k) K122526 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026