Video Colposcope
FDA 510(k) clearance K151878 · decided 2015-12-01
Clearance details
- K-number
- K151878
- Device name
- Video Colposcope
- Applicant
- Edan Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-07-09
- Decision date
- 2015-12-01
- Days to decision
- 145 days
- Clearance type
- Traditional
- Product code
- HEX
- Device class
- 2
- Regulation number
- 884.1630
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Shenzhen, CN
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Smart Scope® CX (K233043) | Periwinkle Technologies Pvt., Ltd. | 2024-06-14 |
| Gynescope System (K190187) | Illumigyn , Ltd. | 2019-05-08 |
| Biop Digital Colposcope (K182764) | Biop Medical , Ltd. | 2018-11-27 |
| Pocket Colposcope System (K181034) | Hadleigh Health Technologies, LLC | 2018-09-21 |
| LT-300 SD Digital Video Colposcope (K170446) | Lutech Industries, Inc. | 2017-05-21 |
| EVA (Enhanced Visual Assessment) System (K161871) | Mobileodt , Ltd. | 2016-12-19 |
| Colposcope System (K160341) | Xuzhou Kernel Medical Equipment Co., Ltd. | 2016-09-14 |
| LT-300 HD (K160380) | Lutech Industries, Inc. | 2016-05-13 |
| LT-300 Video Colposcope (K143119) | Lutech Industries, Inc. | 2014-12-18 |
| COOPER SURGICAL LEISEGANG COLPOSCOPE SYSTEM (K140754) | CooperSurgical, Inc. | 2014-10-23 |
| THE GYNOCULAR (K132423) | Gynius AB | 2014-04-08 |
| GC-3000E DIGITAL COLPOSCOPE (K122311) | Shenzhen Goldcare Meditech Co., Ltd. | 2013-09-18 |
Recalls involving this device
No recalls on record reference this clearance.