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FDA 510(k)

KARL STORZ ENDOVISION UROCAM/HYSTEROCAM

K-Number: K940283 · 1994-09-28

ApplicantMedical Concepts, Inc.
Decision Date1994-09-28
Product CodeFET
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

KARL STORZ ENDOVISION UROCAM/HYSTEROCAM is the device name listed in this FDA 510(k) record. The listed applicant is Medical Concepts, Inc.. It received FDA 510(k) clearance on 1994-09-28 under 510(k) number K940283. The device is classified under product code FET. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KARL STORZ ENDOVISION UROCAM/HYSTEROCAM?

KARL STORZ ENDOVISION UROCAM/HYSTEROCAM is a medical device that received FDA 510(k) clearance on 1994-09-28. The listed applicant is Medical Concepts, Inc.. The 510(k) number is K940283.

When did KARL STORZ ENDOVISION UROCAM/HYSTEROCAM receive FDA 510(k) clearance?

KARL STORZ ENDOVISION UROCAM/HYSTEROCAM received FDA 510(k) clearance on 1994-09-28, under 510(k) number K940283.

Who is the listed applicant for KARL STORZ ENDOVISION UROCAM/HYSTEROCAM?

The FDA 510(k) record lists Medical Concepts, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KARL STORZ ENDOVISION UROCAM/HYSTEROCAM?

The FDA product code for KARL STORZ ENDOVISION UROCAM/HYSTEROCAM is FET.

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Other records listing Medical Concepts, 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.

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Related Devices (Code: FET)

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

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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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