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.
Clearance details
- Applicant
- Ad-Tech Medical Instrument Corporation
- Product code
- Code HBE
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Racine, WI, US
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.