510(k) K122973
- Device
- AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE
- Applicant
- MEDGYN PRODUCTS, INC.
- 510(k) number
- K122973
- Product code
- HEX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-06-12
- Date received
- 2012-09-26
- Regulation
- 884.1630
- Classification name
- Colposcope (and Colpomicroscope)
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- STEPHANIE BLAIR
- Address
- 12 S. First Stree 12th Floor San Jose CA US 95113 95113
FDA Registration Numbers#
- 9611604
- 3008393409
- 1927430
- 3010395077
- 3005216736
- 3010390468
- 3003969012
- 2249760
- 3006179052
- 1450908
- 3035387162
- 3016250458
- 3036423383
- 3006667212
- 3009201600
- 3016965604
- 1216677
- 3032109
- 3007532396
Source Documents#
Other 510(k) Records For Product Code HEX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233043 | Smart Scope® CX | Periwinkle Technologies Pvt., Ltd. | 2024-06-14 |
| K190187 | Gynescope System | Illumigyn , Ltd. | 2019-05-08 |
| K182764 | Biop Digital Colposcope | Biop Medical , Ltd. | 2018-11-27 |
| K181034 | Pocket Colposcope System | Hadleigh Health Technologies, LLC | 2018-09-21 |
| K170446 | LT-300 SD Digital Video Colposcope | Lutech Industries, Inc. | 2017-05-21 |
| K161871 | EVA (Enhanced Visual Assessment) System | Mobileodt , Ltd. | 2016-12-19 |
| K160341 | Colposcope System | Xuzhou Kernel Medical Equipment Co., Ltd. | 2016-09-14 |
| K160380 | LT-300 HD | Lutech Industries, Inc. | 2016-05-13 |
| K151878 | Video Colposcope | Edan Instruments, Inc. | 2015-12-01 |
| K143119 | LT-300 Video Colposcope | Lutech Industries, Inc. | 2014-12-18 |
| K140754 | COOPER SURGICAL LEISEGANG COLPOSCOPE SYSTEM | CooperSurgical, Inc. | 2014-10-23 |
| K132423 | THE GYNOCULAR | Gynius AB | 2014-04-08 |
| K122311 | GC-3000E DIGITAL COLPOSCOPE | Shenzhen Goldcare Meditech Co., Ltd. | 2013-09-18 |
| K110147 | ULTRASIGHTHD C31 WITH IMAGESENSE AND REMOTE VIEWER TELEMEDICINE | Sti Medical Systems, LLC | 2011-04-08 |
| K092433 | DYSIS | Forth Photonics Hellas SA | 2011-03-10 |
Legacy Summary#
summary
FDA Review#
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