Product code HEX
- Device name
- Colposcope (And Colpomicroscope)
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation number
- 884.1630
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 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 |
| K122973 | AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE | Medgyn Products, Inc. | 2013-06-12 |
| 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 |
| K090324 | ULTRASIGHT HD DIGITAL COLPOSCOPY WITH IMAGESENSE TECHNOLOGY | Sti Medical Systems | 2010-12-20 |
| K101141 | SEILER COLPOSCOPE, MODELS 935, 955 AND 985 | Seiler Precision Microscopes | 2010-08-06 |
| K100595 | ECLERIS MICROSTAR COLPOSCOPE | Ecleris USA | 2010-07-09 |
| K072691 | CERVICAL MD, MODEL C10 | Sti Medical Systems | 2008-01-31 |
| K073053 | COLPO-MASTER | United Products & Instruments, Inc. | 2007-11-15 |
| K070845 | SOUNMED COLOPOSCOPE COLPO-99/99PLUS | Sounmed, Inc. | 2007-10-12 |
| K061306 | CO-1000 COLPOSCOPE, MULTIPLE | Gynex Corp. | 2006-08-07 |
| K033870 | IMAGE MANAGEMENT SYSTEM | Welch Allyn, Inc. | 2004-03-12 |
| K031436 | MEDISCOPE | Sometech Corporation | 2003-12-19 |
| K031639 | INTERMED ZOOM COLPOSCOPE | Intermed Group, Inc. | 2003-08-22 |
| K021153 | GOLDWAY DIGITAL VIDEO COLPOSCOPE IMAGING SYSTEM, MODEL #SLC-2000 | Goldway Us, Inc. | 2003-02-10 |
| K021854 | DFV CPG COLPOSCOPE | D.F. Vasconcellos S.A. | 2002-10-25 |
| K001314 | MEDSCOPE | All-Pro Imaging Corp. | 2000-07-25 |
| K000707 | LEICA COLPOSCOPE | Leica Microscopy Systems , Ltd. | 2000-06-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| B366U1C200WR01 | MICROSCOPE Colposcope | Ecleris | 2024-02-13 |
| B366U1C200TR01 | MICROSCOPE Colposcope | Ecleris | 2024-02-13 |
| B366U1C200FR01 | MICROSCOPE Colposcope | Ecleris | 2024-02-13 |
| 05060477110188 | DYSIS Ultra 2.0 | DYSIS MEDICAL LIMITED | 2019-02-22 |
| 17290016976028 | EVA System | MOBILEODT LTD | 2018-11-20 |
| 05060477110065 | DYSIS Ultra | DYSIS MEDICAL LIMITED | 2018-03-25 |
| M803010466SA1 | medgyn video colposcope | MEDGYN PRODUCTS, INC. | 2017-02-13 |
| 05060477110003 | DYSIS v3 Digital Colposcope | DYSIS MEDICAL LIMITED | 2016-09-12 |
| 05060477110010 | DYSIS v3 Digital Colposcope | DYSIS MEDICAL LIMITED | 2016-09-12 |
| M803010200 | MedGyn Gynescope | MEDGYN PRODUCTS, INC. | 2016-09-08 |
| M803010198 | MedGyn Gynescope | MEDGYN PRODUCTS, INC. | 2016-09-08 |
| M803010505 | MedGyn Gynescope (Colposcope) | MEDGYN PRODUCTS, INC. | 2016-09-08 |
| M803010500 | MedGyn Gynescope | MEDGYN PRODUCTS, INC. | 2016-09-08 |
| M803010469 | MedGyn Video Colposcope | MEDGYN PRODUCTS, INC. | 2016-09-08 |
| M803010466 | MedGyn Video Colposcope | MEDGYN PRODUCTS, INC. | 2016-09-08 |
| 10607151011397 | Bovie | ASPEN SURGICAL PRODUCTS, INC. | 2016-08-29 |
| 10607151011380 | Bovie | ASPEN SURGICAL PRODUCTS, INC. | 2016-08-29 |
| 10607151011373 | Bovie | ASPEN SURGICAL PRODUCTS, INC. | 2016-08-29 |
| 10607151011366 | Bovie | ASPEN SURGICAL PRODUCTS, INC. | 2016-08-29 |
| 10607151011359 | Bovie | ASPEN SURGICAL PRODUCTS, INC. | 2016-08-29 |
| 10607151011342 | Bovie | ASPEN SURGICAL PRODUCTS, INC. | 2016-08-29 |
| 10607151011335 | Bovie | ASPEN SURGICAL PRODUCTS, INC. | 2016-08-29 |
| 10607151011328 | Bovie | ASPEN SURGICAL PRODUCTS, INC. | 2016-08-29 |
| 10607151011311 | Bovie | ASPEN SURGICAL PRODUCTS, INC. | 2016-08-29 |
| 10607151011304 | Bovie | ASPEN SURGICAL PRODUCTS, INC. | 2016-08-29 |
| 10607151011281 | Bovie | ASPEN SURGICAL PRODUCTS, INC. | 2016-08-29 |
| 10607151011267 | Bovie | ASPEN SURGICAL PRODUCTS, INC. | 2016-08-29 |
| 10607151011243 | Bovie | ASPEN SURGICAL PRODUCTS, INC. | 2016-08-29 |
| 10607151011236 | Bovie | ASPEN SURGICAL PRODUCTS, INC. | 2016-08-29 |
| 10607151011229 | Bovie | ASPEN SURGICAL PRODUCTS, INC. | 2016-08-29 |