510(k) K250705
- Device
- Sonata Transcervical Fibroid Ablation System 2.2
- Applicant
- Gynesonics, Inc.
- 510(k) number
- K250705
- Product code
- KNF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-04-02
- Date received
- 2025-03-10
- Regulation
- 884.4160
- Classification name
- Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Christine Ehmann
- Address
- 600 Chesapeake Dr. Redwood City CA US 94063 94063
FDA Registration Numbers#
- 3010155661
- 2183744
- 9611102
- 3006546082
- 2029275
- 3013247477
- 9680515
- 3003418325
- 3012322232
- 9617070
- 2954783
- 9610612
- 1043214
- 2244478
- 3014334038
- 1320894
- 3013875526
- 3002807310
- 2916714
- 8010456
- 9610773
- 3027454635
- 3016271578
- 1055236
- 3005809810
- 3004111573
- 3008693678
- 3009881188
- 3004491689
- 1061927
- 8010877
- 3010707607
- 3011050570
- 3012507533
- 3004636440
- 9610617
- 3010202439
- 3007699067
- 3015972753
- 2030624
- 1649518
- 1930027
- 2936485
- 2031093
- 2020550
- 3014342096
- 1225798
- 1319639
- 3004608878
- 3016096098
- 1054241
- 3005875675
- 3009420598
Source Documents#
Other 510(k) Records For Product Code KNF#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240503 | Sonata Transcervical Fibroid Ablation System 2.2 | Gynesonics, Inc. | 2024-07-17 |
| K233848 | Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220) | Gynesonics, Inc. | 2023-12-21 |
| K222304 | Sonata Transcervical Fibroid Ablation System 2.2 | Gynesonics, Inc. | 2022-11-08 |
| K211535 | Sonata Transcervical Fibroid Ablation System 2.2 | Gynesonics, Inc. | 2021-06-17 |
| K193516 | Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 | Gynesonics, Inc. | 2020-05-04 |
| K173703 | Sonata Sonography-Guided Transcervical Fibroid Ablation System | Gynesonics, Inc. | 2018-08-15 |
| K132135 | LINA GOLD LOOP HC | Lina Medical Aps | 2014-01-31 |
| K121343 | MODULAP LOOP | Atc Technologies, Inc. | 2013-06-14 |
| K103726 | JARIT TAKE-APART ENDOSCOPIC INSTRUMENTS | Integra LifeSciences Corporation | 2012-02-08 |
| K092897 | LAP LOOP | Medsys, S.A. | 2010-02-01 |
| K070315 | LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8 | Lina Medical Aps | 2007-10-30 |
| K022979 | LAPARETTE, MODEL LAP J L S H N | Instruments Medicaux G.B., Inc. | 2002-12-18 |
| K010752 | AESCULAP'S MODULAR ENDOSCOPIC INSTRUMENTS FOR GYNECOLOGY | Aesculap, Inc. | 2001-06-11 |
| K003405 | ENDOSCOPIC MONOPOLAR FORCEPS-SCISSORS, EMF-2000 TO 2999,ENDOSCOPICS MONOPOLARFOEPS-GRASPERS, EMF-3000 TO 3999, ENDOSCOPO | Highland / Marietta, Inc. | 2001-05-07 |
| K010425 | EPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY) | Hdc Corp. | 2001-03-15 |