Codman Disposable Perforators— 510(k) K183581

Substantially Equivalent

Integra Lifesciences Corp.

FDA 510(k) clearance K183581 for Codman Disposable Perforators, Substantially Equivalent on 2019-01-20. Applicant: Integra Lifesciences Corp..

Clearance details

Applicant: Integra Lifesciences Corp.
Product code: Code HBF
Advisory panel: Neurology
Date received: 2018-12-21
Decision date: 2019-01-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Mansfield, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HBF

product code HBF

Injury: 587
Malfunction: 621
Other: 1
Total: 1,209

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.