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FDA 510(k)

AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F)

K-Number: K980492 · 1998-11-17

ApplicantCircon Acmi
Decision Date1998-11-17
Product CodeFFK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F) is the device name listed in this FDA 510(k) record. The listed applicant is Circon Acmi. It received FDA 510(k) clearance on 1998-11-17 under 510(k) number K980492. 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 AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F)?

AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F) is a medical device that received FDA 510(k) clearance on 1998-11-17. The listed applicant is Circon Acmi. The 510(k) number is K980492.

When did AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F) receive FDA 510(k) clearance?

AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F) received FDA 510(k) clearance on 1998-11-17, under 510(k) number K980492.

Who is the listed applicant for AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F)?

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

What is the FDA product code for AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F)?

The FDA product code for AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F) is FFK.

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Other records listing Circon Acmi as applicant

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K013165USA SERIES LAPAROSCOPESK905706GYN-1500 HYSTEROSCOPIC INUFFLATORK905705LAP 3501 HIGH FLOW INSUFFLATORK884097MORRIS ANTI-SPLATTER DEVICE FOR ENDOSCOPESK884025CIRCON ACMI BICAP II THERAPEUTIC SYSTEM BC-200K884254CIRCON ACMI BICAP III THERAPEUTIC SYSTEM

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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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