510(k) K143308
K143308 is an FDA 510(k) premarket notification submitted by Applied Medical Resources for the device "GelPOINT Transvaginal Access Platform". The FDA issued a decision of Substantially Equivalent on October 13, 2015. The device falls under product code HEW (Culdoscope (And Accessories)), a Class II device regulated under 21 CFR 884.1640. Applied Medical Resources has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 13, 2015
- Date Received
- November 18, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Culdoscope (And Accessories)
- Device Class
- Class II
- Regulation Number
- 884.1640
- Review Panel
- OB
- Submission Type