510(k) K191294
K191294 is an FDA 510(k) premarket notification submitted by Applied Medical Resources Corp. for the device "Transvaginal Access Platform". The FDA issued a decision of Substantially Equivalent on September 6, 2019. The device falls under product code HEW (Culdoscope (And Accessories)), a Class II device regulated under 21 CFR 884.1640. Applied Medical Resources Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 6, 2019
- Date Received
- May 14, 2019
- 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