injeTAK Adjustable Tip Needle (DIS199; DIS201)— 510(k) K241523
Substantially EquivalentLaborie Medical Technologies, Corp.
FDA 510(k) clearance K241523 for injeTAK Adjustable Tip Needle (DIS199; DIS201), Substantially Equivalent on 2024-08-27. Applicant: Laborie Medical Technologies, Corp..
Clearance details
- Applicant
- Laborie Medical Technologies, Corp.
- Product code
- Code FBK
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Portsmouth, NH, US
Adverse events under product code FBK
product code FBK- Other
- 1
- Total
- 1
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.