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AUTOLITH TOUCH - Autolith Touch

FDA 510(k)

Class II (US FDA 510(k))

510(k) K130368

by Northgate Technologies Inc.

Identifiers

510(k) Number: K130368 FDA 510(k)
FDA Product Code: FFK FDA 510(k)
Models / Variants: Autolith Touch FDA 510(k)
Uro Touch FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 876.4480 FDA 510(k)
Regulation Number: 876.4480 FDA 510(k)
Advisory Committee: Gastroenterology, Urology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

AUTOLITH TOUCH - Autolith Touch by Northgate Technologies Inc. — Class II — FDA_510K — listed in FDA 510(k) — 2 models — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer: Northgate Technologies Inc.
FDA Applicant: Northgate Technologies, Inc.

Sources (1)

FDA 510(k) K130368 24 fields · synced Jun 18, 2026