WANG/MILL-ROSE PLEURAL BIOPSY NEEDLE— 510(k) K942630
Substantially EquivalentMill-Rose Laboratory
FDA 510(k) clearance K942630 for WANG/MILL-ROSE PLEURAL BIOPSY NEEDLE, Substantially Equivalent on 1994-07-12. Applicant: Mill-Rose Laboratory. Device class: 2.
Clearance details
- Applicant
- Mill-Rose Laboratory
- Product code
- Code KNW
- Device class
- Class 2
- Regulation
- 21 CFR 876.1075
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mentor, OH, US
Recent devices under product code KNW
view allMore clearances from Mill-Rose Laboratory
view all- K983122 — MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) COMBINATION CYTOLOGY/HISTOLOGY PROCEDURAL KIT
- K983124 — MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) CYTOLOGY PROCEDURAL KIT
- K971275 — MILL-ROSE DISPOSABLE POLYPECTOMY SNARE
- K962736 — MILL-ROSE LARYNGOSCOPIC INJECTION NEEDLE
- K960880 — MILL-ROSE BLIND MICROBIOLOGY BRUSH
Adverse events under product code KNW
product code KNW- Death
- 9
- Injury
- 965
- Malfunction
- 10,444
- Other
- 3
- Total
- 11,421
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.