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FDA 510(k)

AUTOLITH TOUCH; URO TOUCH

K-Number: K130368 · 2013-11-15

ApplicantNorthgate Technologies, Inc.
Decision Date2013-11-15
Product CodeFFK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AUTOLITH TOUCH; URO TOUCH is the device name listed in this FDA 510(k) record. The listed applicant is Northgate Technologies, Inc.. It received FDA 510(k) clearance on 2013-11-15 under 510(k) number K130368. The device is classified under product code FFK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOLITH TOUCH; URO TOUCH?

AUTOLITH TOUCH; URO TOUCH is a medical device that received FDA 510(k) clearance on 2013-11-15. The listed applicant is Northgate Technologies, Inc.. The 510(k) number is K130368.

When did AUTOLITH TOUCH; URO TOUCH receive FDA 510(k) clearance?

AUTOLITH TOUCH; URO TOUCH received FDA 510(k) clearance on 2013-11-15, under 510(k) number K130368.

Who is the listed applicant for AUTOLITH TOUCH; URO TOUCH?

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

What is the FDA product code for AUTOLITH TOUCH; URO TOUCH?

The FDA product code for AUTOLITH TOUCH; URO TOUCH is FFK.

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Related Devices (Code: FFK)

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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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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