FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Sonata Transcervical Fibroid Ablation System 2.2
K Number: K250705
·
Decision Apr 2, 2025
Classifications
1
FEI Numbers
54
Registration Numbers
54
Same Product Code
43
Applicant Total
4
Review Days
23
Basic Information
- Device Name
- Sonata Transcervical Fibroid Ablation System 2.2
- K Number
- K250705
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 884.4160
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gynesonics, Inc.
- Date Received
- March 10, 2025
- Decision Date
- April 2, 2025
- Product Code
- KNF
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KNF | Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KNF), ordered by most recent decision date.
Sonata Transcervical Fibroid Ablation System 2.2
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Sonata Transcervical Fibroid Ablation System 2.2
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Sonata Transcervical Fibroid Ablation System 2.2
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Sonata Sonography-Guided Transcervical Fibroid Ablation System
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Gynesonics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K222304 | Sonata Transcervical Fibroid Ablation System 2.2 | Nov 8, 2022 | Substantially Equivalent |
| K211535 | Sonata Transcervical Fibroid Ablation System 2.2 | Jun 17, 2021 | Substantially Equivalent |
| K173703 | Sonata Sonography-Guided Transcervical Fibroid Ablation System | Aug 15, 2018 | Substantially Equivalent |