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FDA 510(k)

4.5 F LITHOTRIPTOR ELECTRODE

K-Number: K830086 · 1983-02-09

ApplicantMonaghan Medical Corp.
Decision Date1983-02-09
Product CodeFFK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

4.5 F LITHOTRIPTOR ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Monaghan Medical Corp.. It received FDA 510(k) clearance on 1983-02-09 under 510(k) number K830086. 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 4.5 F LITHOTRIPTOR ELECTRODE?

4.5 F LITHOTRIPTOR ELECTRODE is a medical device that received FDA 510(k) clearance on 1983-02-09. The listed applicant is Monaghan Medical Corp.. The 510(k) number is K830086.

When did 4.5 F LITHOTRIPTOR ELECTRODE receive FDA 510(k) clearance?

4.5 F LITHOTRIPTOR ELECTRODE received FDA 510(k) clearance on 1983-02-09, under 510(k) number K830086.

Who is the listed applicant for 4.5 F LITHOTRIPTOR ELECTRODE?

The FDA 510(k) record lists Monaghan Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 4.5 F LITHOTRIPTOR ELECTRODE?

The FDA product code for 4.5 F LITHOTRIPTOR ELECTRODE 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.

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.K230488EL27-Compact; Sterile EHL-ProbesWalz Elektronik GmbHK202813URO-TOUCH 9 French ProbeNorthgate Technologies, Inc.K191124Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.AK162119UreTron PF Series ProbeMed-Sonics Corp.

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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