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FDA 510(k)

THE KARL STORZ UROMAT(TM)

K-Number: K940983 · 1994-09-20

ApplicantKARL STORZ Endoscopy-America, Inc.
Decision Date1994-09-20
Product CodeLJH
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

THE KARL STORZ UROMAT(TM) is the device name listed in this FDA 510(k) record. The listed applicant is KARL STORZ Endoscopy-America, Inc.. It received FDA 510(k) clearance on 1994-09-20 under 510(k) number K940983. The device is classified under product code LJH. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE KARL STORZ UROMAT(TM)?

THE KARL STORZ UROMAT(TM) is a medical device that received FDA 510(k) clearance on 1994-09-20. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K940983.

When did THE KARL STORZ UROMAT(TM) receive FDA 510(k) clearance?

THE KARL STORZ UROMAT(TM) received FDA 510(k) clearance on 1994-09-20, under 510(k) number K940983.

Who is the listed applicant for THE KARL STORZ UROMAT(TM)?

The FDA 510(k) record lists KARL STORZ Endoscopy-America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE KARL STORZ UROMAT(TM)?

The FDA product code for THE KARL STORZ UROMAT(TM) is LJH.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing KARL STORZ Endoscopy-America, 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.

K252624KARL STORZ Laryngoscopes and AccessoriesK240506KARL STORZ HoldersK223885HOPKINS TelescopesK230359KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula,l. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle (26167NA); Puncture Needle, LUER-lock (26178R); Suction a. Irrig. Cannula,L. 43cm (37460LH); Suction a. Irrig. Cannula,L. 36cm (37360LH); Puncture Needle, dia. 1.6 mm, 36 cm (26175R); Two-Way Stopcock (26167H); Injection Needle, LUER-K223520UNIDRIVE SIII SystemK223923HOPKINS Telescopes

View all 355 devices →

Related Devices (Code: LJH)

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.

K254111Irrigation/Urology SetsB.Braun Medical, Inc.K162992Karl Storz UROMAT E.A.S.I.Karl Storz Endoscopy America, Inc.K070873AMSURE BLADDER IRRIGATION SETAmsino Intl., Inc.K071832MODIFCATION TO: SPYGLASS IRRIGATION SYSTEMMedical Scientific, Inc.K063700SPYGLASS IRRIGATION SYSTEMMedical Scientific, Inc.K062551NEXUS IRRIGATION TUBING SETNexus Medical, LLC

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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