FDA 510(k)

URO-TOUCH 9 French Probe

K-Number: K202813 · 2021-06-14

Decision Date2021-06-14

Product CodeFFK

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

URO-TOUCH 9 French Probe is a medical device manufactured by Northgate Technologies, Inc.. It received FDA 510(k) clearance on 2021-06-14 under approval 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. It is manufactured by Northgate Technologies, Inc.. The 510(k) number is K202813.

When was URO-TOUCH 9 French Probe approved by the FDA?

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

What company makes URO-TOUCH 9 French Probe?

URO-TOUCH 9 French Probe is manufactured by Northgate Technologies, Inc..

What is the FDA product code for URO-TOUCH 9 French Probe?

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

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Related Devices (Code: FFK)

K162119UreTron PF Series ProbeMed-Sonics Corp. K160198UreTron MultiProbe Lithotripter SystemMed-Sonics Corp. K191124Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A K230488EL27-Compact; Sterile EHL-ProbesWalz Elektronik GmbH K242888Electrohydraulic Lithotriptor (TCS-B3-II)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. K243032EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.

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.