FDA product code MOK: Vaginoscope And Accessories
MOK is the FDA product code for vaginoscope and accessories. It is a Class II device, regulated under 21 CFR 884.1630 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 2 510(k) submissions under MOK, 1 in the last five years, from 2 different applicants. The average 510(k) review took 146 days (median 146).
Classification
| Field | Value |
|---|---|
| Device name | Vaginoscope And Accessories |
| Device class | Class II |
| Regulation | 21 CFR 884.1630 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MOK
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 165 |
Compare with all 510(k) review times · Search every MOK clearance
Top MOK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Applied Medical Resources Corporation | 1 | 2022-09-16 |
| KARL STORZ Endoscopy-America, Inc. | 1 | 1995-06-19 |
Most recent MOK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K220969 | Applied Medical Resources Corporation | GelPOINT V-Path Vaginal Access System | 2022-09-16 | 165 |
| K950639 | KARL STORZ Endoscopy-America, Inc. | KARL STORZ INFANT, BALLOON VAGINOSCOPE, VAGINOSCOPE SHEATH, FIBER OPTIC LIGHT CARRIERS, ADJUSTABLE MAGNIFIERS | 1995-06-19 | 126 |
Recalls for MOK devices
openFDA lists no recalls for product code MOK.
Frequently asked questions
What is FDA product code MOK?
MOK is the FDA product code for vaginoscope and accessories. It is a Class II device, regulated under 21 CFR 884.1630 and reviewed by the Obstetrics and Gynecology panel.
What device class is MOK?
Class II, regulation 21 CFR 884.1630. Typical premarket route: 510(k).
How long does a 510(k) take for product code MOK?
Across 2 cleared submissions the average was 146 days from receipt to decision (median 146).
Which companies have the most MOK clearances?
Applied Medical Resources Corporation (1); KARL STORZ Endoscopy-America, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MOK
- Run a recall and safety report across every MOK manufacturer
- Watch product code MOK for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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