ONE/CIRC (CIRCUMCISION CLAMP)— 510(k) K900370

Name: FDA 510(k) clearance K900370
Creator: U.S. Food and Drug Administration
Published: 1990-04-16

Substantially Equivalent

Bionix Development Corp.

FDA 510(k) clearance K900370 for ONE/CIRC (CIRCUMCISION CLAMP), Substantially Equivalent on 1990-04-16. Applicant: Bionix Development Corp.. Device class: 2.

Clearance details

Applicant: Bionix Development Corp.
Product code: Code HFX
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 1990-01-25
Decision date: 1990-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toledo, OH, 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.