FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device
K Number: K223508
·
Decision Dec 22, 2022
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
53
Applicant Total
209
Review Days
30
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Basic Information
- Device Name
- Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device
- K Number
- K223508
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronic, Inc.
- Date Received
- November 22, 2022
- Decision Date
- December 22, 2022
- Product Code
- OCL
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| OCL | Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue | FDA class 2 | General, Plastic Surgery |
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