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FDA 510(k)

KAISHOU VAGINAL SPECULUM

K-Number: K030761 · 2003-06-09

Decision Date2003-06-09
Product CodeHIB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

KAISHOU VAGINAL SPECULUM is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Kaishou Medical Apparatus Co., Ltd.. It received FDA 510(k) clearance on 2003-06-09 under 510(k) number K030761. The device is classified under product code HIB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KAISHOU VAGINAL SPECULUM?

KAISHOU VAGINAL SPECULUM is a medical device that received FDA 510(k) clearance on 2003-06-09. The listed applicant is Jiangsu Kaishou Medical Apparatus Co., Ltd.. The 510(k) number is K030761.

When did KAISHOU VAGINAL SPECULUM receive FDA 510(k) clearance?

KAISHOU VAGINAL SPECULUM received FDA 510(k) clearance on 2003-06-09, under 510(k) number K030761.

Who is the listed applicant for KAISHOU VAGINAL SPECULUM?

The FDA 510(k) record lists Jiangsu Kaishou Medical Apparatus Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KAISHOU VAGINAL SPECULUM?

The FDA product code for KAISHOU VAGINAL SPECULUM is HIB.

Related Clinical Trials

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.

Related Devices (Code: HIB)

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.

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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