FDA 510(k)

KARL STORZ XENON 300 LIGHT SOURCE FOR NON-FLASH APPLICATIONS

K-Number: K962595 · 1996-09-04

ApplicantKARL STORZ Endoscopy-America, Inc.

Decision Date1996-09-04

Product CodeFFS

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

KARL STORZ XENON 300 LIGHT SOURCE FOR NON-FLASH APPLICATIONS 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 1996-09-04 under 510(k) number K962595. The device is classified under product code FFS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KARL STORZ XENON 300 LIGHT SOURCE FOR NON-FLASH APPLICATIONS?

KARL STORZ XENON 300 LIGHT SOURCE FOR NON-FLASH APPLICATIONS is a medical device that received FDA 510(k) clearance on 1996-09-04. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K962595.

When did KARL STORZ XENON 300 LIGHT SOURCE FOR NON-FLASH APPLICATIONS receive FDA 510(k) clearance?

KARL STORZ XENON 300 LIGHT SOURCE FOR NON-FLASH APPLICATIONS received FDA 510(k) clearance on 1996-09-04, under 510(k) number K962595.

Who is the listed applicant for KARL STORZ XENON 300 LIGHT SOURCE FOR NON-FLASH APPLICATIONS?

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 KARL STORZ XENON 300 LIGHT SOURCE FOR NON-FLASH APPLICATIONS?

The FDA product code for KARL STORZ XENON 300 LIGHT SOURCE FOR NON-FLASH APPLICATIONS is FFS.

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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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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.