FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
Biopsy Forceps
K Number: K252722
·
Decision Sep 30, 2025
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
22
Applicant Total
1
Review Days
33
Basic Information
- Device Name
- Biopsy Forceps
- K Number
- K252722
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.4075
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fehling Instruments GmbH
- Date Received
- August 28, 2025
- Decision Date
- September 30, 2025
- Product Code
- DWZ
- Advisory Committee
- Cardiovascular
- 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 |
|---|---|---|---|
| DWZ | Device, Biopsy, Endomyocardial | FDA class 2 | Cardiovascular |
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