HEX — Colposcope (And Colpomicroscope) Class II
FDA Device Classification
Classification Details
- Product Code
- HEX
- Device Class
- Class II
- Regulation Number
- 884.1630
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K233043 | periwinkle technologies pvt | Smart Scope® CX | June 14, 2024 |
| K190187 | illumigyn | Gynescope System | May 8, 2019 |
| K182764 | biop medical | Biop Digital Colposcope | November 27, 2018 |
| K181034 | hadleigh health technologies | Pocket Colposcope System | September 21, 2018 |
| K170446 | lutech industries | LT-300 SD Digital Video Colposcope | May 21, 2017 |
| K161871 | mobileodt | EVA (Enhanced Visual Assessment) System | December 19, 2016 |
| K160341 | xuzhou kernel medical equipment co | Colposcope System | September 14, 2016 |
| K160380 | lutech industries | LT-300 HD | May 13, 2016 |
| K151878 | edan instruments | Video Colposcope | December 1, 2015 |
| K143119 | lutech industries | LT-300 Video Colposcope | December 18, 2014 |
| K140754 | coopersurgical | COOPER SURGICAL LEISEGANG COLPOSCOPE SYSTEM | October 23, 2014 |
| K132423 | gynius | THE GYNOCULAR | April 8, 2014 |
| K122311 | shenzhen goldcare meditech co | GC-3000E DIGITAL COLPOSCOPE | September 18, 2013 |
| K122973 | medgyn products | AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE | June 12, 2013 |
| K110147 | sti medical systems | ULTRASIGHTHD C31 WITH IMAGESENSE AND REMOTE VIEWER TELEMEDICINE | April 8, 2011 |
| K092433 | forth photonics hellas | DYSIS | March 10, 2011 |
| K090324 | sti medical systems | ULTRASIGHT HD DIGITAL COLPOSCOPY WITH IMAGESENSE TECHNOLOGY | December 20, 2010 |
| K101141 | seiler precision microscopes | SEILER COLPOSCOPE, MODELS 935, 955 AND 985 | August 6, 2010 |
| K100595 | ecleris usa | ECLERIS MICROSTAR COLPOSCOPE | July 9, 2010 |
| K072691 | sti medical systems | CERVICAL MD, MODEL C10 | January 31, 2008 |