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MICROSTAR Colposcope RX1

by Ecleris

MICROSTAR Colposcope RX1 (U1C100FHD1) is a colposcope (FDA Class II; FDA product code HEX, Colposcope (And Colpomicroscope)) made by Ecleris, cleared under FDA 510(k) K100595 on 9 Jul 2010 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI B366U1C100FHD1RX10), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K100595

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB366U1C100FHD1RX10 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK100595 Date9 Jul 2010DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K100595 decided 9 Jul 2010 Active
  • FDA GUDID UDI-DI B366U1C100FHD1RX10 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K100595
  2. Listed FDA GUDID B366U1C100FHD1RX10

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
MICROSTAR Colposcope
Generic name
Colposcope
Model / Ref / Catalog
RX1, U1C100FHD1
Primary DI / UDI-DI
B366U1C100FHD1RX10
510(k) Number
FDA product code
HEX
GMDN term
Colposcope
Device class
Class II
Regulation number
884.1630
GUDID distribution status
In Commercial Distribution

Related devices

Category: Colposcope

Cleared under the same submission (K100595)

and 8 more cleared under K100595

Similar devices

Other devices filed under FDA product code HEX (Colposcope (And Colpomicroscope)).

Other devices from Ecleris

See all devices from Ecleris →

Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)