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FDA 510(k)

EL27-Compact; Sterile EHL-Probes

K-Number: K230488 · 2023-08-31

ApplicantWalz Elektronik GmbH
Decision Date2023-08-31
Product CodeFFK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EL27-Compact; Sterile EHL-Probes is the device name listed in this FDA 510(k) record. The listed applicant is Walz Elektronik GmbH. It received FDA 510(k) clearance on 2023-08-31 under 510(k) 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. The listed applicant is Walz Elektronik GmbH. The 510(k) number is K230488.

When did EL27-Compact; Sterile EHL-Probes receive FDA 510(k) clearance?

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

Who is the listed applicant for EL27-Compact; Sterile EHL-Probes?

The FDA 510(k) record lists Walz Elektronik GmbH as the applicant. This does not by itself establish the device manufacturer.

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)

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.

K243032EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.K242888Electrohydraulic Lithotriptor (TCS-B3-II)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.K202813URO-TOUCH 9 French ProbeNorthgate Technologies, Inc.K191124Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.AK162119UreTron PF Series ProbeMed-Sonics Corp.K160198UreTron MultiProbe Lithotripter SystemMed-Sonics Corp.

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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