HEX · Colposcope (And Colpomicroscope)
Obstetrics/Gynecology · 21 CFR 884.1630 · Class 2
Overview
| Product Code | HEX |
|---|---|
| Device Name | Colposcope (And Colpomicroscope) |
| Regulation | 21 CFR 884.1630 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| 3rd-Party Reviewable | Yes |
Identification
A colposcope is a device designed to permit direct viewing of the tissues of the vagina and cervix by a telescopic system located outside the vagina. It is used to diagnose abnormalities and select areas for biopsy. This generic type of device may include a light source, cables, and component parts.
Classification Rationale
Class II (special controls). The device, when it is a standard colposcope (or colpomicroscope) that uses only a white light source, does not use filters other than a green filter, does not include image analysis software, and is not smartphone-based, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
Special Controls
*Classification.* Class II (special controls). The device, when it is a standard colposcope (or colpomicroscope) that uses only a white light source, does not use filters other than a green filter, does not include image analysis software, and is not smartphone-based, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
Recent Cleared Devices (20 of 56)
Showing 20 most recent of 56 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K233043 | Smart Scope® CX | Periwinkle Technologies Pvt., Ltd. | Jun 14, 2024 | SESE |
| K190187 | Gynescope System | Illumigyn , Ltd. | May 8, 2019 | SESE |
| K182764 | Biop Digital Colposcope | Biop Medical , Ltd. | Nov 27, 2018 | SESE |
| K181034 | Pocket Colposcope System | Hadleigh Health Technologies, LLC | Sep 21, 2018 | SESE |
| K170446 | LT-300 SD Digital Video Colposcope | Lutech Industries, Inc. | May 21, 2017 | SESE |
| K161871 | EVA (Enhanced Visual Assessment) System | Mobileodt , Ltd. | Dec 19, 2016 | SESE |
| K160341 | Colposcope System | Xuzhou Kernel Medical Equipment Co., Ltd. | Sep 14, 2016 | SESE |
| K160380 | LT-300 HD | Lutech Industries, Inc. | May 13, 2016 | SESE |
| K151878 | Video Colposcope | Edan Instruments, Inc. | Dec 1, 2015 | SESE |
| K143119 | LT-300 Video Colposcope | Lutech Industries, Inc. | Dec 18, 2014 | SESE |
| K140754 | COOPER SURGICAL LEISEGANG COLPOSCOPE SYSTEM | CooperSurgical, Inc. | Oct 23, 2014 | SESE |
| K132423 | THE GYNOCULAR | Gynius AB | Apr 8, 2014 | SESE |
| K122311 | GC-3000E DIGITAL COLPOSCOPE | Shenzhen Goldcare Meditech Co., Ltd. | Sep 18, 2013 | SESE |
| K122973 | AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE | Medgyn Products, Inc. | Jun 12, 2013 | SESE |
| K110147 | ULTRASIGHTHD C31 WITH IMAGESENSE AND REMOTE VIEWER TELEMEDICINE | Sti Medical Systems, LLC | Apr 8, 2011 | SESE |
| K092433 | DYSIS | Forth Photonics Hellas SA | Mar 10, 2011 | SESE |
| K090324 | ULTRASIGHT HD DIGITAL COLPOSCOPY WITH IMAGESENSE TECHNOLOGY | Sti Medical Systems | Dec 20, 2010 | SESE |
| K101141 | SEILER COLPOSCOPE, MODELS 935, 955 AND 985 | Seiler Precision Microscopes | Aug 6, 2010 | SESE |
| K100595 | ECLERIS MICROSTAR COLPOSCOPE | Ecleris USA | Jul 9, 2010 | SESE |
| K072691 | CERVICAL MD, MODEL C10 | Sti Medical Systems | Jan 31, 2008 | SESE |
Top Applicants
- Wallach Surgical Devices, Inc. — 4 clearances
- Dynatech Cryomedical Co. — 3 clearances
- Lutech Industries, Inc. — 3 clearances
- CooperSurgical, Inc. — 2 clearances
- Hill-Med, Inc. — 2 clearances
