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FDA 510(k)

5F ELECTRODE(LITHOTRIPTOR)

K-Number: K852874 · 1985-08-21

ApplicantNorthgate Research, Inc.
Decision Date1985-08-21
Product CodeFFK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

5F ELECTRODE(LITHOTRIPTOR) is the device name listed in this FDA 510(k) record. The listed applicant is Northgate Research, Inc.. It received FDA 510(k) clearance on 1985-08-21 under 510(k) number K852874. 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 5F ELECTRODE(LITHOTRIPTOR)?

5F ELECTRODE(LITHOTRIPTOR) is a medical device that received FDA 510(k) clearance on 1985-08-21. The listed applicant is Northgate Research, Inc.. The 510(k) number is K852874.

When did 5F ELECTRODE(LITHOTRIPTOR) receive FDA 510(k) clearance?

5F ELECTRODE(LITHOTRIPTOR) received FDA 510(k) clearance on 1985-08-21, under 510(k) number K852874.

Who is the listed applicant for 5F ELECTRODE(LITHOTRIPTOR)?

The FDA 510(k) record lists Northgate Research, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 5F ELECTRODE(LITHOTRIPTOR)?

The FDA product code for 5F ELECTRODE(LITHOTRIPTOR) is FFK.

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Other records listing Northgate Research, Inc. 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.

K9033371.9 FRENCH LITHOTRIPTER ELECTRODEK8947042.5 FRENCH LITHOTRIPTOR ELECTRODEK891253UROLOGICAL GRASPING FORCEPSK891254UROLOGICAL STONE BASKETK891252UROLOGICAL LOOP RETRIEVERSK8649043F ELECTRODE

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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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