GelPOINT V-Path Vaginal Access System
FDA 510(k) K220969 · Applied Medical Resources Corporation
510(k) numberK220969
Submission
- Device name
- GelPOINT V-Path Vaginal Access System
- Applicant
- Applied Medical Resources Corporation
Rancho Santa, CA, US - Received
- April 4, 2022
- Decision date
- September 16, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MOK – Vaginoscope And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1630
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code MOK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K950639 | Karl Storz Infant, Balloon Vaginoscope, Vaginoscope Sheath, Fiber Optic Light Carriers…MOK · Traditional | KARL STORZ Endoscopy-America, Inc. | 06/19/1995SE |
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Questions and answers
When was GelPOINT V-Path Vaginal Access System cleared by the FDA?
GelPOINT V-Path Vaginal Access System (K220969) received a 510(k) decision of Substantially Equivalent on September 16, 2022, 165 days after the submission was received.
What is the product code of K220969?
The FDA product code is MOK – Vaginoscope And Accessories, a Class II (moderate risk) device regulated under 21 CFR 884.1630.