510(k) K202427
K202427 is an FDA 510(k) premarket notification submitted by Gtimd, LLC for the device "Aqueduct 100 Plus Cervical Dilation Balloon Catheter". The FDA issued a decision of Substantially Equivalent on November 6, 2020. The device falls under product code PON (Catheter, Balloon, Dilation Of Cervical Canal), a Class II device regulated under 21 CFR 884.4260. Gtimd, LLC has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 6, 2020
- Date Received
- August 25, 2020
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Balloon, Dilation Of Cervical Canal
- Device Class
- Class II
- Regulation Number
- 884.4260
- Review Panel
- OB
- Submission Type
Mechanical dilation and softening of the cervix.