FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI
K Number: K220053
·
Decision Feb 4, 2022
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
45
Applicant Total
64
Review Days
29
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Basic Information
- Device Name
- Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI
- K Number
- K220053
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.4300
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fujifilm Corporation
- Date Received
- January 6, 2022
- Decision Date
- February 4, 2022
- Product Code
- KGE
- 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 |
|---|---|---|---|
| KGE | Forceps, Biopsy, Electric | FDA class 2 | Gastroenterology, Urology |
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