3D LINE STEROTACTIC HARDWARE ACCESSORIES— 510(k) K011255
Substantially Equivalent3D Line USA, Inc.
FDA 510(k) clearance K011255 for 3D LINE STEROTACTIC HARDWARE ACCESSORIES, Substantially Equivalent on 2001-12-20. Applicant: 3D Line USA, Inc.. Device class: 2.
Clearance details
- Applicant
- 3D Line USA, 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
- Baltimore, MD, US
Recent devices under product code HAW
view allMore clearances from 3D Line USA, 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 K011255
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K011255.
Data sourced from openFDA. This site is unofficial and independent of the FDA.