510(k) K193516
K193516 is an FDA 510(k) premarket notification submitted by Gynesonics, Inc. for the device "Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1". The FDA issued a decision of Substantially Equivalent on May 4, 2020. The device falls under product code KNF (Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)), a Class II device regulated under 21 CFR 884.4160. Gynesonics, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 4, 2020
- Date Received
- December 19, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
- Device Class
- Class II
- Regulation Number
- 884.4160
- Review Panel
- OB
- Submission Type