Circumplast Circumcision Device— 510(k) K151095

Substantially Equivalent

Novadien Healthcare

FDA 510(k) clearance K151095 for Circumplast Circumcision Device, Substantially Equivalent on 2015-09-18. Applicant: Novadien Healthcare.

Clearance details

Applicant: Novadien Healthcare
Product code: Code HFX
Advisory panel: Obstetrics/Gynecology
Date received: 2015-04-23
Decision date: 2015-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mount Lewis, AU

Download summary PDF View on FDA.gov ↗

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.