Ion-L Navigated Instruments— 510(k) K262121
Substantially EquivalentSurGenTec, LLC
FDA 510(k) clearance K262121 for Ion-L Navigated Instruments, Substantially Equivalent on 2026-07-24. Applicant: SurGenTec, LLC. Device class: 2.
Clearance details
- Applicant
- SurGenTec, LLC
- Product code
- 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
- Boca Raton, FL, US
Recent devices under product code OLO
view allMore clearances from SurGenTec, LLC
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.