FDA 510(k)

STORZ MODULITH SLK LITHOTRIPTER WITH MULTIVIEW OPTION

K-Number: K012482 · 2001-10-16

ApplicantKARL STORZ Endoscopy-America, Inc.

Decision Date2001-10-16

Product CodeLNS

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

STORZ MODULITH SLK LITHOTRIPTER WITH MULTIVIEW OPTION 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 2001-10-16 under 510(k) number K012482. The device is classified under product code LNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STORZ MODULITH SLK LITHOTRIPTER WITH MULTIVIEW OPTION?

STORZ MODULITH SLK LITHOTRIPTER WITH MULTIVIEW OPTION is a medical device that received FDA 510(k) clearance on 2001-10-16. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K012482.

When did STORZ MODULITH SLK LITHOTRIPTER WITH MULTIVIEW OPTION receive FDA 510(k) clearance?

STORZ MODULITH SLK LITHOTRIPTER WITH MULTIVIEW OPTION received FDA 510(k) clearance on 2001-10-16, under 510(k) number K012482.

Who is the listed applicant for STORZ MODULITH SLK LITHOTRIPTER WITH MULTIVIEW OPTION?

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 STORZ MODULITH SLK LITHOTRIPTER WITH MULTIVIEW OPTION?

The FDA product code for STORZ MODULITH SLK LITHOTRIPTER WITH MULTIVIEW OPTION is LNS.

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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: LNS)

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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.