FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
FROG Forceps Valve (VAL1-F1-100)
K Number: K221264
·
Decision Jun 1, 2022
Classifications
1
FEI Numbers
80
Registration Numbers
80
Same Product Code
71
Applicant Total
2
Review Days
30
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Basic Information
- Device Name
- FROG Forceps Valve (VAL1-F1-100)
- K Number
- K221264
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fujifilm Medwork GmbH
- Date Received
- May 2, 2022
- Decision Date
- June 1, 2022
- Product Code
- ODC
- 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 |
|---|---|---|---|
| ODC | Endoscope Channel Accessory | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Fujifilm Medwork GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K210625 | JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve | Sep 10, 2021 | Substantially Equivalent |