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FDA 510(k)

GC-3000E DIGITAL COLPOSCOPE

K-Number: K122311 · 2013-09-18

ApplicantShenzhen Goldcare Meditech Co., Ltd.
Decision Date2013-09-18
Product CodeHEX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

GC-3000E DIGITAL COLPOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Goldcare Meditech Co., Ltd.. It received FDA 510(k) clearance on 2013-09-18 under 510(k) number K122311. The device is classified under product code HEX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GC-3000E DIGITAL COLPOSCOPE?

GC-3000E DIGITAL COLPOSCOPE is a medical device that received FDA 510(k) clearance on 2013-09-18. The listed applicant is Shenzhen Goldcare Meditech Co., Ltd.. The 510(k) number is K122311.

When did GC-3000E DIGITAL COLPOSCOPE receive FDA 510(k) clearance?

GC-3000E DIGITAL COLPOSCOPE received FDA 510(k) clearance on 2013-09-18, under 510(k) number K122311.

Who is the listed applicant for GC-3000E DIGITAL COLPOSCOPE?

The FDA 510(k) record lists Shenzhen Goldcare Meditech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GC-3000E DIGITAL COLPOSCOPE?

The FDA product code for GC-3000E DIGITAL COLPOSCOPE is HEX.

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Related Devices (Code: HEX)

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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