Cleared Traditional

K251687 - Konig Bell Circumcision Clamp (FDA 510(k) Clearance)

Feb 2026
Decision
268d
Days
Class 2
Risk

K251687 is an FDA 510(k) clearance for the Konig Bell Circumcision Clamp. This device is classified as a Clamp, Circumcision (Class II - Special Controls, product code HFX).

Submitted by Medline Industries, LP (Northfiled, US). The FDA issued a Cleared decision on February 25, 2026, 268 days after receiving the submission on June 2, 2025.

This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number K251687 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2025
Decision Date February 25, 2026
Days to Decision 268 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code HFX — Clamp, Circumcision
Device Class Class II - Special Controls
CFR Regulation 21 CFR 884.4530