KILEJIAN CIRCUMCISION TEMPLATE [THE DOME]— 510(k) K945949

Name: FDA 510(k) clearance K945949
Creator: U.S. Food and Drug Administration
Published: 1995-07-25

Substantially Equivalent

Vlm Surgical, Inc.

FDA 510(k) clearance K945949 for KILEJIAN CIRCUMCISION TEMPLATE [THE DOME], Substantially Equivalent on 1995-07-25. Applicant: Vlm Surgical, Inc.. Device class: 2.

Clearance details

Applicant: Vlm Surgical, Inc.
Product code: Code HFX
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 1994-12-06
Decision date: 1995-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Medford, OR, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HFX

product code HFX

Other: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.