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FDA 510(k)

KSEA CALCUSPLIT

K-Number: K992114 · 1999-08-18

ApplicantKarl Storz Endoscopy
Decision Date1999-08-18
Product CodeFFK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

KSEA CALCUSPLIT is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz Endoscopy. It received FDA 510(k) clearance on 1999-08-18 under 510(k) number K992114. 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 KSEA CALCUSPLIT?

KSEA CALCUSPLIT is a medical device that received FDA 510(k) clearance on 1999-08-18. The listed applicant is Karl Storz Endoscopy. The 510(k) number is K992114.

When did KSEA CALCUSPLIT receive FDA 510(k) clearance?

KSEA CALCUSPLIT received FDA 510(k) clearance on 1999-08-18, under 510(k) number K992114.

Who is the listed applicant for KSEA CALCUSPLIT?

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

What is the FDA product code for KSEA CALCUSPLIT?

The FDA product code for KSEA CALCUSPLIT is FFK.

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Other records listing Karl Storz Endoscopy 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.

K043375FISCH TITANIUM MIDDLE EAR PROSTHESESK030848PERFORATED BIOABSORBABLE INTERFERENCE SCREW MEGAFIXK030009KSEA POWERSHAVER SYSTEM S2K023924AUTOCON II 200 ELECTROSURGICAL GENERATORK023187KSEA SPINOSCOPEK011700MODULITH SLK LITHOTRIPTER

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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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