NDI PASSIVE SPHERES— 510(k) K033621
Substantially EquivalentNorthern Digital, Inc.
FDA 510(k) clearance K033621 for NDI PASSIVE SPHERES, Substantially Equivalent on 2004-01-27. Applicant: Northern Digital, Inc.. Device class: 2.
Clearance details
- Applicant
- Northern Digital, 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
- Traditional
- Location
- Dundas, CA
Recent devices under product code HAW
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 K033621
K-number listed on FDA's recall record- Z-1578-2014 — BAG 9732315 MOUSE STERILE 15 PK
- Z-1579-2014 — BIOPSY NEEDLE KIT, 9733068, PASSIVE
- Z-1580-2014 — BIT 9733516 2.9mm DRILL STERILE
- Z-1581-2014 — DISP 9730950 STRL SPHERE, 1 PK INSERT
- Z-1582-2014 — DISP 9730951 STRL SPHERE, 5PK INSERT
- Z-1583-2014 — DRAPE 9732722 TUBE STERILE O-ARM 20PK
- Z-1584-2014 — ENT PRGM 9734636 ADD FUSION NAV AxiEM
- Z-1585-2014 — INST 9731132 KIT CR REF FRAME DRIVER 5PK
- Z-1586-2014 — INSTRUMENT TRACKER 9733533XOM ENT 1PK
- Z-1587-2014 — KIT, 9731427, THORACIC TACTILE PROBES
- Z-1588-2014 — MOUSE 9732721 STERILE O-ARM 10PK
- Z-1589-2014 — PACK 9731975 TUMOR RESECTION AXIEM CR
- Z-1590-2014 — PAK 9733497 NAV NIM-SPINE PEDICLE ACC KT
- Z-1591-2014 — PATIENT TRACKER 9733534XOM ENT 1PK
- Z-1592-2014 — PIN, 9733235, 100MM, STERILE, PERC REF
- Z-1593-2014 — PIN, 9733236, 150MM, STERILE, PERC REF
- Z-1594-2014 — SHUNT KIT 9733605 NON-INVASIVE
- Z-1595-2014 — SPHERES 8801071 1/TRAY 12PK
- Z-1596-2014 — SPHERES 8801075 5/TRAY 12PK
- Z-1597-2014 — TRAJ GUIDE KIT, 9733065, BIOPSY, EXT
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K033621.
Data sourced from openFDA. This site is unofficial and independent of the FDA.