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FDA 510(k)

KSEA CALCUSON

K-Number: K973251 · 1998-06-22

ApplicantKARL STORZ Endoscopy-America, Inc.
Decision Date1998-06-22
Product CodeFEO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

KSEA CALCUSON 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 1998-06-22 under 510(k) number K973251. The device is classified under product code FEO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KSEA CALCUSON?

KSEA CALCUSON is a medical device that received FDA 510(k) clearance on 1998-06-22. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K973251.

When did KSEA CALCUSON receive FDA 510(k) clearance?

KSEA CALCUSON received FDA 510(k) clearance on 1998-06-22, under 510(k) number K973251.

Who is the listed applicant for KSEA CALCUSON?

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 CALCUSON?

The FDA product code for KSEA CALCUSON is FEO.

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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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Related Devices (Code: FEO)

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.

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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.

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