ECLERIS MICROSTAR COLPOSCOPE

Colposcope (and Colpomicroscope)

Ecleris USA

The following data is part of a premarket notification filed by Ecleris Usa with the FDA for Ecleris Microstar Colposcope.

Pre-market Notification Details

Device IDK100595
510k NumberK100595
Device Name:ECLERIS MICROSTAR COLPOSCOPE
ClassificationColposcope (and Colpomicroscope)
Applicant Ecleris USA 12225 WORLD TRADE DRIVE SUITE K San Diego,  CA  92128
ContactRaymond J Kelly Iv
CorrespondentRaymond J Kelly Iv
Ecleris USA 12225 WORLD TRADE DRIVE SUITE K San Diego,  CA  92128
Product CodeHEX  
CFR Regulation Number884.1630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-03-02
Decision Date2010-07-09

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B366U1C100W3R000 K100595 000
B366U1C200FR02 K100595 000
B366U1C200TR02 K100595 000
B366U1C200WR02 K100595 000
B366U1C100A5EIR000 K100595 000
B366U1C100A5R000 K100595 000
B366U1C100F1R010 K100595 000
B366U1C100F2R010 K100595 000
B366U1C100FHD1RX10 K100595 000
B366U1C100T1R000 K100595 000
B366U1C200AR01 K100595 000

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