FDA 510(k)

KSEA SEMI-RIGID HYSTEROSCOPE AND ACCESSORIES

K-Number: K971518 · 1997-07-24

ApplicantKARL STORZ Endoscopy-America, Inc.

Decision Date1997-07-24

Product CodeHIH

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

KSEA SEMI-RIGID HYSTEROSCOPE AND 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 1997-07-24 under 510(k) number K971518. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KSEA SEMI-RIGID HYSTEROSCOPE AND ACCESSORIES?

KSEA SEMI-RIGID HYSTEROSCOPE AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 1997-07-24. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K971518.

When did KSEA SEMI-RIGID HYSTEROSCOPE AND ACCESSORIES receive FDA 510(k) clearance?

KSEA SEMI-RIGID HYSTEROSCOPE AND ACCESSORIES received FDA 510(k) clearance on 1997-07-24, under 510(k) number K971518.

Who is the listed applicant for KSEA SEMI-RIGID HYSTEROSCOPE AND 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 KSEA SEMI-RIGID HYSTEROSCOPE AND ACCESSORIES?

The FDA product code for KSEA SEMI-RIGID HYSTEROSCOPE AND ACCESSORIES is HIH.

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Other records listing KARL STORZ Endoscopy-America, Inc. as applicant

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Related Devices (Code: HIH)

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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.