MICROTARGETING STAR DRIVE SYSTEM, COMPONENTS— 510(k) K092562
Substantially EquivalentFHC, Inc.
FDA 510(k) clearance K092562 for MICROTARGETING STAR DRIVE SYSTEM, COMPONENTS, Substantially Equivalent on 2009-09-18. Applicant: FHC, Inc.. Device class: 2.
Clearance details
- Applicant
- FHC, Inc.
- Product code
- Code HAW
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Bowdoin, ME, US
Recent devices under product code HAW
view allMore clearances from FHC, Inc.
view allAdverse events under product code HAW
product code HAW- Death
- 52
- Injury
- 1,083
- Malfunction
- 17,300
- Total
- 18,435
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 →
Recalls naming K092562
K-number listed on FDA's recall record- Z-2349-2018 — microTargeting" STar" Drive System (Manual), Product Number ST-DS-MA
- Z-2350-2018 — microTargeting" STar" Drive System (Motorized), Product Number ST-DS-ME
- Z-2351-2018 — microTargeting" STar" Drive System (Manual), Product Number 70-ZD-MA
- Z-2352-2018 — microTargeting" STar" Drive System (Motorized), Product Number 70-ZD-ME
- Z-2354-2018 — microTargeting" Lead Adapter for STar" Drive, Product Number 70-CN-DB
- Z-2357-2018 — microTargeting" STar" Drive System (Manual) Distributed by Medtronic, Product Number FC8001
- Z-2358-2018 — microTargeting" STar" Drive System (Motorized) Distributed by Medtronic, Product Number FC8002
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K092562.
Data sourced from openFDA. This site is unofficial and independent of the FDA.