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

Substantially Equivalent

Vlm Surgical, Inc.

Clearance details

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

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.