PRIMADO SURGICAL DRILL— 510(k) K080722

Substantially Equivalent

Nakanishi, Inc.

FDA 510(k) clearance K080722 for PRIMADO SURGICAL DRILL, Substantially Equivalent on 2008-09-17. Applicant: Nakanishi, Inc..

Clearance details

Applicant: Nakanishi, Inc.
Product code: Code ERL
Advisory panel: Ear, Nose, Throat
Date received: 2008-03-13
Decision date: 2008-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code ERL

product code ERL

Malfunction: 11,234
Total: 11,234

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.