KILEJIAN CIRCUMCISOR— 510(k) K010867

Substantially Equivalent

Iris Surgical, LLC

FDA 510(k) clearance K010867 for KILEJIAN CIRCUMCISOR, Substantially Equivalent on 2001-05-03. Applicant: Iris Surgical, LLC.

Clearance details

Applicant: Iris Surgical, LLC
Product code: Code HFX
Advisory panel: Obstetrics/Gynecology
Date received: 2001-03-22
Decision date: 2001-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St.Augustine, FL, US

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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.