AD-TECH'S BRAIN BIOPSY NEEDLE FOR STEREOTAXIC— 510(k) K924348
Substantially EquivalentAd-Tech Medical Instrument Corp
FDA 510(k) clearance K924348 for AD-TECH'S BRAIN BIOPSY NEEDLE FOR STEREOTAXIC, Substantially Equivalent on 1992-11-23. Applicant: Ad-Tech Medical Instrument Corp. Device class: 2.
Clearance details
- Applicant
- Ad-Tech Medical Instrument Corp
- 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
- Racine, WI, US
Recent devices under product code HAW
view allMore clearances from Ad-Tech Medical Instrument Corp
view all- K112094 — BRAIN BIOPSY NEEDLE
- K053363 — DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODES
- K053358 — DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES
- K041604 — MACRO-MICRO DEPTH ELECTRODE
- K990788 — AD-TECH'S FORAMEN OVALE ELECTRODE
Adverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.