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FDA 510(k)

URO-TOUCH 9 French Probe

K-Number: K202813 · 2021-06-14

ApplicantNorthgate Technologies, Inc.
Decision Date2021-06-14
Product CodeFFK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

URO-TOUCH 9 French Probe 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 2021-06-14 under 510(k) number K202813. 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 URO-TOUCH 9 French Probe?

URO-TOUCH 9 French Probe is a medical device that received FDA 510(k) clearance on 2021-06-14. The listed applicant is Northgate Technologies, Inc.. The 510(k) number is K202813.

When did URO-TOUCH 9 French Probe receive FDA 510(k) clearance?

URO-TOUCH 9 French Probe received FDA 510(k) clearance on 2021-06-14, under 510(k) number K202813.

Who is the listed applicant for URO-TOUCH 9 French Probe?

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 URO-TOUCH 9 French Probe?

The FDA product code for URO-TOUCH 9 French Probe is FFK.

Other records listing Northgate Technologies, 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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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