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FDA 510(k)

EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA)

K-Number: K012445 · 2001-08-24

ApplicantElectro Medical Systems SA
Decision Date2001-08-24
Product CodeFFK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA) is the device name listed in this FDA 510(k) record. The listed applicant is Electro Medical Systems SA. It received FDA 510(k) clearance on 2001-08-24 under 510(k) number K012445. 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 EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA)?

EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA) is a medical device that received FDA 510(k) clearance on 2001-08-24. The listed applicant is Electro Medical Systems SA. The 510(k) number is K012445.

When did EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA) receive FDA 510(k) clearance?

EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA) received FDA 510(k) clearance on 2001-08-24, under 510(k) number K012445.

Who is the listed applicant for EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA)?

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

What is the FDA product code for EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA)?

The FDA product code for EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA) is FFK.

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Other records listing Electro Medical Systems SA as applicant

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.

K022328EMS PIEZON MASTER 600K022119EMS AIR-FLOW HANDY 2 DENTAL HANDPIECEK002484EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVALK992251SWISS LITHOCLAST MULTIPURPOSE PROBEK963285EMS SWISS LITHOCLAST LITHOTRIPTERK964111LITHOVAC SUCTION/ASPIRATION PROBE

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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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