CORUS Navigation System-GN— 510(k) K261665
Substantially EquivalentProvidence Medical Technology, Inc.
FDA 510(k) clearance K261665 for CORUS Navigation System-GN, Substantially Equivalent on 2026-06-18. Applicant: Providence Medical Technology, Inc.. Device class: 2.
Summary
Providence Medical Technology's CORUS Navigation System-GN is filed under OLO, orthopedic stereotaxic instruments. The record doesn't say what the "GN" suffix refers to or list components.
Class II, 21 CFR 882.4560. The Orthopedic review panel handled it as a Special 510(k); the record lists Neurology as the classification panel.
Providence filed from Pleasanton, California. The decision came 29 calendar days after receipt (May 20 to June 18, 2026).
Clearance details
- Applicant
- Providence Medical Technology, Inc.
- Product code
- Product code OLO
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Pleasanton, CA, US
Recent devices under product code OLO
view allMore clearances from Providence Medical Technology, Inc.
view allAdverse events under product code OLO
product code OLO- Death
- 11
- Injury
- 2,799
- Malfunction
- 11,105
- Other
- 1
- Total
- 13,916
Source: openFDA MAUDE database, through . 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.