FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
CURIS II RF Generator (REF 360100-05)
K Number: K251813
·
Decision Feb 11, 2026
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
9
Review Days
243
Basic Information
- Device Name
- CURIS II RF Generator (REF 360100-05)
- K Number
- K251813
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sutter Medizintechnik GmbH
- Date Received
- June 13, 2025
- Decision Date
- February 11, 2026
- Product Code
- GEI
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GEI), ordered by most recent decision date.
Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CoolSeal Generator® (CSL-200-90)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NEUROMARK System (NMK00301)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LAP-iX2N
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OsteoCool RF Ablation System; OsteoCool 2.0 RF Ablation System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MILAN System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Sutter Medizintechnik GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K233425 | FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035) | Jan 25, 2024 | Substantially Equivalent |
| K193587 | Sutter Swyng non-stick bipolar forceps, single-use | Feb 10, 2020 | Substantially Equivalent |
| K192128 | Sutter Arrowtip Monopolar Electrodes | Oct 4, 2019 | Substantially Equivalent |
| K191732 | Sutter RaVoR Bipolar Electrodes | Aug 30, 2019 | Substantially Equivalent |
| K171869 | Sutter CURIS RF Generator | Feb 23, 2018 | Substantially Equivalent |
| K150959 | Sutter Bipolar Forceps-Calvian | Sep 10, 2015 | Substantially Equivalent |
| K131012 | SUTTER BIPOLAR FORCEPS - SUPERGLISS | Aug 23, 2013 | Substantially Equivalent |
| K073450 | SUTTER ELECTROSURGICAL CABLES | Mar 17, 2008 | Substantially Equivalent |