DeviceClearance

Konig Bell Circumcision Clamp— 510(k) K251687

Substantially Equivalent

Medline Industries, LP

FDA 510(k) clearance K251687 for Konig Bell Circumcision Clamp, Substantially Equivalent on 2026-02-25. Applicant: Medline Industries, LP. Device class: 2.

Summary

Medline Industries' Konig Bell Circumcision Clamp is filed under product code HFX, circumcision clamp. The record gives no models or description beyond the name.

Class II, 21 CFR 884.4530. Obstetrics/Gynecology is both the classification panel and the review panel, and it came in as a Traditional 510(k).

The record lists the applicant location as Northfiled, Illinois. The substantially equivalent decision came 268 calendar days after receipt (June 2, 2025 to February 25, 2026).

Clearance details

Applicant
Medline Industries, LP
Product code
Product code HFX
Device class
Class 2
Regulation
21 CFR 884.4530
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Northfiled, IL, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code HFX

product code HFX
Other
3
Total
3

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.