Vaginoscope And Accessories
The Vaginoscope and Accessories is an obstetrics/gynecology device used to visualize the vaginal canal and cervix for diagnostic and therapeutic purposes, often used in pediatric patients or in cases where a standard speculum cannot be used. Classified as FDA Class 2 under 21 CFR 884.1630, it requires 510(k) premarket notification. The product code is MOK, and it is eligible for third-party 510(k) review.
Research product code MOK in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- MOK
- Device Class
- FDA class 2
- Regulation Number
- 884.1630
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K220969 | GelPOINT V-Path Vaginal Access System | Sep 16, 2022 | Substantially Equivalent | Applied Medical Resources Corporation |
| K950639 | KARL STORZ INFANT, BALLOON VAGINOSCOPE, VAGINOSCOPE SHEATH, FIBER OPTIC LIGHT CARRIERS, ADJUSTABLE MAGNIFIERS | Jun 19, 1995 | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. |
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.