FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Konig Bell Circumcision Clamp
K Number: K251687
·
Decision Feb 25, 2026
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
26
Applicant Total
29
Review Days
268
Basic Information
- Device Name
- Konig Bell Circumcision Clamp
- K Number
- K251687
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medline Industries, LP
- Date Received
- June 2, 2025
- Decision Date
- February 25, 2026
- Product Code
- HFX
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HFX | Clamp, Circumcision | FDA class 2 | Obstetrics/Gynecology |
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