510(k) K220969
K220969 is an FDA 510(k) premarket notification submitted by Applied Medical Resources Corporation for the device "GelPOINT V-Path Vaginal Access System". The FDA issued a decision of Substantially Equivalent on September 16, 2022. The device falls under product code MOK (Vaginoscope And Accessories), a Class II device regulated under 21 CFR 884.1630. Applied Medical Resources Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 16, 2022
- Date Received
- April 4, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Vaginoscope And Accessories
- Device Class
- Class II
- Regulation Number
- 884.1630
- Review Panel
- OB
- Submission Type