Cranial Drill Bits and Accessories— 510(k) K170442
Substantially EquivalentAd-Tech Medical Instrument Corporation
FDA 510(k) clearance K170442 for Cranial Drill Bits and Accessories, Substantially Equivalent on 2017-09-07. Applicant: Ad-Tech Medical Instrument Corporation. Device class: 2.
Clearance details
- Applicant
- Ad-Tech Medical Instrument Corporation
- Product code
- Code HBE
- Device class
- Class 2
- Regulation
- 21 CFR 882.4310
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Racine, WI, US
Recent devices under product code HBE
view allMore clearances from Ad-Tech Medical Instrument Corporation
view all- K223269 — Spencer Probe Depth Electrodes
- K223276 — Anchor Bolts as Accessories to Depth Electrodes
- K191186 — Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid Electrode, Dual-Sided Interhemispheric Subdural Electrode, Multi-Strip and Slit Grid Subdural Electrode, Intraoperative Mapping Grid Subdural Electrode
- K181544 — Anchor Bolt (as an accessory to Depth Electrodes)
- K163355 — Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes
Adverse events under product code HBE
product code HBE- Injury
- 306
- Malfunction
- 7,175
- Other
- 1
- Total
- 7,482
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 K170442
K-number listed on FDA's recall record- Z-2544-2019 — AD-TECH Drill Sleeve Guides, used with Ad-Tech Placement Kits: (a) REF DSG-90-2.3N (b) REF DSG-6.3-090-2.4N
- Z-2539-2018 — AD-TECH Medical Instrument Corporation Drill Sleeve Guides DSG-6-3-090-2.4N utilizing raw material (RM0677) from the following lots from vendor 00-0001062., AD0021502, AD0021628. Product Usage: The drill sleeve guides are accessories to the Ad-Tech Cranial Drill Bits. The Cranial Drill Bits and accessories are intended to be used for drilling holes in the skull for neurological procedures, such as brain biopsy, brain contacting electrode and electrode accessory device placement. The DSG-6.3-090-2.4N drill sleeve guides are intended to be used with the 2.4mm Cranial Drill Bit diameter.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K170442.
Data sourced from openFDA. This site is unofficial and independent of the FDA.