FDA 510(k)

EL27-Compact; Sterile EHL-Probes

K-Number: K230488 · 2023-08-31

Decision Date2023-08-31

Product CodeFFK

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

EL27-Compact; Sterile EHL-Probes is a medical device manufactured by Walz Elektronik GmbH. It received FDA 510(k) clearance on 2023-08-31 under approval number K230488. 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 EL27-Compact; Sterile EHL-Probes?

EL27-Compact; Sterile EHL-Probes is a medical device that received FDA 510(k) clearance on 2023-08-31. It is manufactured by Walz Elektronik GmbH. The 510(k) number is K230488.

When was EL27-Compact; Sterile EHL-Probes approved by the FDA?

EL27-Compact; Sterile EHL-Probes received FDA 510(k) clearance on 2023-08-31, under approval number K230488.

What company makes EL27-Compact; Sterile EHL-Probes?

EL27-Compact; Sterile EHL-Probes is manufactured by Walz Elektronik GmbH.

What is the FDA product code for EL27-Compact; Sterile EHL-Probes?

The FDA product code for EL27-Compact; Sterile EHL-Probes is FFK.

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 K202813URO-TOUCH 9 French ProbeNorthgate Technologies, Inc. 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.