MOK · Vaginoscope And Accessories
Obstetrics/Gynecology · 21 CFR 884.1630 · Class 2
Overview
| Product Code | MOK |
|---|---|
| Device Name | Vaginoscope And Accessories |
| 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 (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K220969 | GelPOINT V-Path Vaginal Access System | Applied Medical Resources Corporation | Sep 16, 2022 | SESE |
| K950639 | KARL STORZ INFANT, BALLOON VAGINOSCOPE, VAGINOSCOPE SHEATH, FIBER OPTIC LIGHT CARRIERS, ADJUSTABLE MAGNIFIERS | KARL STORZ Endoscopy-America, Inc. | Jun 19, 1995 | SESE |
Top Applicants
- Applied Medical Resources Corporation — 1 clearance
- KARL STORZ Endoscopy-America, Inc. — 1 clearance
