Colpo-Master
by United Products & Instruments
510(k) K073053
Colpo-Master is a medical device (FDA Class II; FDA product code HEX, Colposcope (And Colpomicroscope)) made by United Products & Instruments, cleared under FDA 510(k) K073053 on 15 Nov 2007, active as of 8 Nov 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK073053 | Date15 Nov 2007 | StatusActive |
Official records
- FDA 510(k) database K073053
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HEX
- FDA applicant
- United Products & Instruments, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 884.1630
- Advisory committee
- Obstetrics/Gynecology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K073053
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Bovie CS-103LED | CS-103LED | 00840113235582 | On the market | |
| Bovie CS-103LED | CS-103LED / CS-103LED | 10607151011229 | No longer on the market | |
| Bovie CS-103T-DV | CS-103T-DV | 00840113235575 | On the market | |
| Bovie CS-103T-DV | CS-103T-DV / CS-103T-DV | 10607151011236 | No longer on the market | |
| Bovie CS-103T-LED | CS-103T-LED | 00840113235568 | On the market | |
| Bovie CS-103T-LED | CS-103T-LED / CS-103T-LED | 10607151011243 | No longer on the market | |
| Bovie CS-103T-SDV | CS-103T-SDV / CS-103T-SDV | 10607151011267 | No longer on the market | |
| Bovie CS-103T-SV | CS-103T-SV / CS-103T-SV | 10607151011281 | No longer on the market | |
| Bovie CS-105LED | CS-105LED | 00840113235551 | On the market | |
| Bovie CS-105LED | CS-105LED / CS-105LED | 10607151011311 | No longer on the market | |
| Bovie CS-105T-LED | CS-105T-LED | 00840113235452 | On the market | |
| Bovie CS-105T-LED | CS-105T-LED / CS-105T-LED | 10607151011328 | No longer on the market | |
| Bovie CS-205LED | CS-205LED | 00840113235469 | On the market | |
| Bovie CS-205LED | CS-205LED / CS-205LED | 10607151011335 | No longer on the market | |
| Bovie CS-205T-DV | CS-205T-DV / CS-205T-DV | 10607151011342 | No longer on the market | |
| Bovie CS-205T-LED | CS-205T-LED | 00840113235537 | On the market | |
| Bovie CS-205T-LED | CS-205T-LED / CS-205T-LED | 10607151011359 | No longer on the market | |
| Bovie CS-205T-SDV | CS-205T-SDV | 00840113235513 | On the market | |
| Bovie CS-205T-SDV | CS-205T-SDV / CS-205T-SDV | 10607151011366 | No longer on the market | |
| Bovie CS-205T-SV | CS-205T-SV / CS-205T-SV | 10607151011373 | No longer on the market | |
| Bovie CS-305 | CS-305 / CS-305 | 10607151011397 | No longer on the market | |
| Bovie CS103T-SVM | CS103T-SVM / CS103T-SVM | 10607151011304 | No longer on the market | |
| Bovie CS205T-SVM | CS205T-SVM / CS205T-SVM | 10607151011380 | No longer on the market | |
| Henry Schein 5700144 | 5700144 / 5700144 | 00304040019795 | On the market | |
| Henry Schein 5700145 | 5700145 / 5700145 | 00304040019801 | On the market | |
| Henry Schein 5700146 | 5700146 / 5700146 | 00304040019818 | On the market | |
| Henry Schein 5700147 | 5700147 / 5700147 | 00304040019825 | On the market | |
| Henry Schein 5700148 | 5700148 / 5700148 | 00304040019832 | On the market | |
| Henry Schein 5700149 | 5700149 / 5700149 | 00304040019849 | On the market | |
| Henry Schein 5700150 | 5700150 / 5700150 | 00304040019870 | On the market | |
| Henry Schein 5700221 | 5700221 / 5700221 | 00304040019856 | On the market | |
| Henry Schein 5700226 | 5700226 / 5700226 | 00304040019955 | On the market | |
| Henry Schein 5700227 | 5700227 / 5700227 | 00304040019863 | On the market | |
| Henry Schein 5700228 | 5700228 / 5700228 | 00304040019931 | On the market | |
| Henry Schein 5700229 | 5700229 / 5700229 | 00304040019948 | On the market | |
| Henry Schein 5700230 | 5700230 / 5700230 | 00304040019924 | On the market | |
| Henry Schein 5700231 | 5700231 / 5700231 | 00304040019900 | On the market | |
| Henry Schein 5700232 | 5700232 / 5700232 | 00304040019917 | On the market | |
| McKesson 164 | 164 | 40612479200003 | On the market | |
| McKesson 177 | 177 | 40612479200010 | On the market | |
| McKesson 178 | 178 | 40612479200027 | On the market | |
| McKesson 179 | 179 | 40612479200034 | On the market | |
| McKesson 869 | 869 | 40612479200195 | On the market | |
| UNICO ColpoMaster I CS-103LED | CS-103LED / CS-103LED | 00816668020027 | On the market | |
| UNICO ColpoMaster I CS-103T-LED | CS-103T-LED / CS-103T-LED | 00816668020034 | On the market | |
| UNICO ColpoMaster I CS-105LED | CS-105LED / CS-105LED | 00816668020041 | On the market | |
| UNICO ColpoMaster I CS-105T-LED | CS-105T-LED / CS-105T-LED | 00816668020058 | On the market | |
| UNICO ColpoMaster II CS-205LED | CS-205LED / CS-205LED | 00816668020065 | On the market | |
| UNICO ColpoMaster II CS-205T-LED | CS-205T-LED / CS-205T-LED | 00816668020072 | On the market | |
| UNICO ColpoMaster III CS-305 | CS-305 / CS-305 | 00816668020089 | On the market |
Similar devices
Other devices filed under FDA product code HEX (Colposcope (And Colpomicroscope)).
- CERVISCOPE OPTICAL SYSTEM by Fotomedics, Inc.
- LT-300 SD Digital Video Colposcope by Lutech Industries
- EVA (Enhanced Visual Assessment) System by Mobileodt, Ltd.
- MEDISCOPE by Sometech Corporation
- INTERMED ZOOM COLPOSCOPE by Intermed Group, Inc.
- OCS-2 COLPOSCOPE by Olympus Corp.
- IMT LOUPE-COLPOSCOPE by Inventive Medical Technology
- HM-0660 by Hill-Med, Inc.
- COLPOSCOPE MODEL II by Dynatech Cryomedical Co.
- ECLERIS MICROSTAR COLPOSCOPE by Ecleris USA