510(k) K251687

Konig Bell Circumcision Clamp by Medline Industries, LP — Product Code HFX

K251687 is an FDA 510(k) premarket notification submitted by Medline Industries, LP for the device "Konig Bell Circumcision Clamp". The FDA issued a decision of Substantially Equivalent on February 25, 2026. The device falls under product code HFX (Clamp, Circumcision), a Class II device regulated under 21 CFR 884.4530. Medline Industries, LP has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 2026
Date Received
June 2, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Circumcision
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type