FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
Tornus ES
K Number: K241801
·
Decision Dec 17, 2024
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
473
Applicant Total
84
Review Days
179
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Basic Information
- Device Name
- Tornus ES
- K Number
- K241801
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5010
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Asahi Intecc Co., Ltd.
- Date Received
- June 21, 2024
- Decision Date
- December 17, 2024
- Product Code
- FGE
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | FDA class 2 | Gastroenterology, Urology |
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