FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211)
K Number: K252043
·
Decision Sep 23, 2025
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
43
Review Days
85
Basic Information
- Device Name
- Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211)
- K Number
- K252043
- 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
- Olympus Winter & Ibe GmbH
- Date Received
- June 30, 2025
- Decision Date
- September 23, 2025
- Product Code
- GEI
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- EN
- 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 |
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| K Number | Device Name | ||
|---|---|---|---|
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| K221522 | HF-cables (resusable) | Jan 19, 2023 | Substantially Equivalent |
| K223183 | Light-Guide Cables | Jan 13, 2023 | Substantially Equivalent |
| K213207 | Sheath, Stopcock Accessory | Dec 22, 2021 | Substantially Equivalent |
| K203492 | Instrument tray, for semi-rigid ureteroscope | Sep 15, 2021 | Substantially Equivalent |
| K210651 | Resection Electrodes with HF cable | Aug 3, 2021 | Substantially Equivalent |
| K203682 | Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and Divider, Double Action | May 17, 2021 | Substantially Equivalent |
| K203277 | Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps | Apr 28, 2021 | Substantially Equivalent |
| K200369 | OES Elite Ureteroscopes and Accessories | Aug 28, 2020 | Substantially Equivalent |