PRIMADO2 TOTAL SURGICAL SYSTEM— 510(k) K132264

Substantially Equivalent

Nakanishi, Inc.

FDA 510(k) clearance K132264 for PRIMADO2 TOTAL SURGICAL SYSTEM, Substantially Equivalent on 2013-12-17. Applicant: Nakanishi, Inc..

Clearance details

Applicant: Nakanishi, Inc.
Product code: Code HBC
Advisory panel: Neurology
Date received: 2013-07-22
Decision date: 2013-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richardson, TX, US

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Adverse events under product code HBC

product code HBC

Malfunction: 4,715
Total: 4,715

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.