FDA 510(k)

KSEA DISPOSABLE TUBING SET FOR THE UROMAT PUMP

K-Number: K945210 · 1995-02-07

ApplicantKARL STORZ Endoscopy-America, Inc.

Decision Date1995-02-07

Product CodeLJH

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

KSEA DISPOSABLE TUBING SET FOR THE UROMAT PUMP 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 1995-02-07 under 510(k) number K945210. 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 KSEA DISPOSABLE TUBING SET FOR THE UROMAT PUMP?

KSEA DISPOSABLE TUBING SET FOR THE UROMAT PUMP is a medical device that received FDA 510(k) clearance on 1995-02-07. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K945210.

When did KSEA DISPOSABLE TUBING SET FOR THE UROMAT PUMP receive FDA 510(k) clearance?

KSEA DISPOSABLE TUBING SET FOR THE UROMAT PUMP received FDA 510(k) clearance on 1995-02-07, under 510(k) number K945210.

Who is the listed applicant for KSEA DISPOSABLE TUBING SET FOR THE UROMAT PUMP?

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 KSEA DISPOSABLE TUBING SET FOR THE UROMAT PUMP?

The FDA product code for KSEA DISPOSABLE TUBING SET FOR THE UROMAT PUMP is LJH.

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Other records listing KARL STORZ Endoscopy-America, Inc. as applicant

K252624KARL STORZ Laryngoscopes and Accessories K240506KARL STORZ Holders K223885HOPKINS Telescopes K230359KOH 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 System K223923HOPKINS Telescopes

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Related Devices (Code: LJH)

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.