510(k) K253656
- Device
- OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- 510(k) number
- K253656
- Product code
- GEI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-06-05
- Date received
- 2025-11-20
- Regulation
- 878.4400
- Classification name
- Electrosurgical, Cutting & Coagulation & Accessories
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Jeff Sprague
- Address
- 1800 Pyramid Pl. Memphis TN US 38132 38132
FDA Registration Numbers#
- 3004044817
- 3014279513
- 3007029079
- 3007185216
- 3021477808
- 8040537
- 3021519357
- 3007710878
- 3008720584
- 3015806723
- 3006716777
- 1526534
- 9680721
- 3010402752
- 3015460875
- 3013858269
- 3013557681
- 3008849319
- 9613563
- 3010380518
- 3005809810
- 3030626857
- 3011120183
- 3033715699
- 3010377594
- 3007748817
- 3009486890
- 3007583504
- 3007024186
- 3013652305
- 2087572
- 3007960282
- 3012606445
- 1211998
- 8043746
- 3010202439
- 3013551587
- 3036803067
- 3002250546
- 3006849754
- 3010621964
- 3011586151
- 1063285
- 3004837686
- 8010047
- 3004483538
- 3007305485
- 1123137
- 3012497308
- 3013886523
- 9611612
- 9611112
- 3014579161
- 3008114965
- 3010155648
- 9610617
- 3014262693
- 3007535734
- 3016851379
- 3008889904
- 3027645761
- 2020394
- 3012204368
- 3009513193
- 1054811
- 3011987935
- 3006555617
- 3011944170
- 2184009
- 2435119
- 3010188783
- 3013875599
- 1221826
- 3007748793
- 3017196117
- 3015192261
- 9680340
- 1060680
- 3009555600
Source Documents#
Other 510(k) Records For Product Code GEI#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253918 | Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St) | F Care Systems USA, LLC | 2026-06-02 |
| K253803 | MILAN System | Lumenis Be, Ltd. | 2026-06-02 |
| K261202 | ENTire IRE System | Entire Medical , Ltd. | 2026-05-29 |
| K252833 | VIVA combo RF System | Starmed Co., Ltd. | 2026-05-26 |
| K253134 | LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T) | Lagis Enterprise Co., Ltd. | 2026-05-20 |
| K260522 | RhinAer+ Stylus | Aerin Medical, Inc. | 2026-05-18 |
| K253917 | ARION ARC System | Plasma Surgical, Inc. | 2026-04-10 |
| K253777 | Ascblue (8010) | Ascblue Corporation | 2026-04-10 |
| K260466 | Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode) | Zhejiang shuyou Surgical Instrument Co., Ltd. | 2026-04-07 |
| K260397 | SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) | Hironic Co., Ltd. | 2026-04-06 |
| K253405 | Prana System | Prana Surgical | 2026-04-01 |
| K254122 | FLOW FLEXTEND Wand (72290039) | ArthroCare Corporation | 2026-03-30 |
| K260255 | AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001) | Aventix Medical, Inc. | 2026-03-27 |
| K253680 | LYNX COBLATION Laryngeal Wand (72290254) | ArthroCare Corporation | 2026-03-25 |
| K253750 | BTL-785NEH | BTL Industries, Inc. | 2026-03-17 |