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FDA 510(k)

KARL STORZ LASER ACCESSORIES

K-Number: K942786 · 1994-09-16

ApplicantKARL STORZ Endoscopy-America, Inc.
Decision Date1994-09-16
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

KARL STORZ LASER ACCESSORIES 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 1994-09-16 under 510(k) number K942786. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KARL STORZ LASER ACCESSORIES?

KARL STORZ LASER ACCESSORIES is a medical device that received FDA 510(k) clearance on 1994-09-16. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K942786.

When did KARL STORZ LASER ACCESSORIES receive FDA 510(k) clearance?

KARL STORZ LASER ACCESSORIES received FDA 510(k) clearance on 1994-09-16, under 510(k) number K942786.

Who is the listed applicant for KARL STORZ LASER ACCESSORIES?

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 LASER ACCESSORIES?

The FDA product code for KARL STORZ LASER ACCESSORIES is GEX. This falls under the Gastroenterology category.

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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

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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