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FDA 510(k)

ECLERIS MICROSTAR COLPOSCOPE

K-Number: K100595 · 2010-07-09

ApplicantEcleris USA
Decision Date2010-07-09
Product CodeHEX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ECLERIS MICROSTAR COLPOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Ecleris USA. It received FDA 510(k) clearance on 2010-07-09 under 510(k) number K100595. 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 ECLERIS MICROSTAR COLPOSCOPE?

ECLERIS MICROSTAR COLPOSCOPE is a medical device that received FDA 510(k) clearance on 2010-07-09. The listed applicant is Ecleris USA. The 510(k) number is K100595.

When did ECLERIS MICROSTAR COLPOSCOPE receive FDA 510(k) clearance?

ECLERIS MICROSTAR COLPOSCOPE received FDA 510(k) clearance on 2010-07-09, under 510(k) number K100595.

Who is the listed applicant for ECLERIS MICROSTAR COLPOSCOPE?

The FDA 510(k) record lists Ecleris USA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ECLERIS MICROSTAR COLPOSCOPE?

The FDA product code for ECLERIS MICROSTAR 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

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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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