Cleared Traditional

Konig Bell Circumcision Clamp

K251687 · Medline Industries, LP · Obstetrics & Gynecology
Feb 2026
Decision
268d
Days
Class 2
Risk

About This 510(k) Submission

K251687 is an FDA 510(k) clearance for the Konig Bell Circumcision Clamp, a Clamp, Circumcision (Class II — Special Controls, product code HFX), submitted by Medline Industries, LP (Nortfield, 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 review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number K251687 FDA.gov
FDA Decision Cleared 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

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