ENDOSCOPIC INJECTION NEEDLE— 510(k) K820973
Substantially EquivalentMill-Rose Laboratory
FDA 510(k) clearance K820973 for ENDOSCOPIC INJECTION NEEDLE, Substantially Equivalent on 1982-04-16. Applicant: Mill-Rose Laboratory. Device class: 2.
Clearance details
- Applicant
- Mill-Rose Laboratory
- Product code
- Code FBK
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code FBK
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 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.