RITE-BITE BIOPSY FORCEPS— 510(k) K951048
Substantially EquivalentMill-Rose Laboratory
FDA 510(k) clearance K951048 for RITE-BITE BIOPSY FORCEPS, Substantially Equivalent on 1995-03-15. Applicant: Mill-Rose Laboratory. Device class: 1.
Clearance details
- Applicant
- Mill-Rose Laboratory
- Product code
- Code FCL
- Device class
- Class 1
- 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 FCL
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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 FCL
product code FCL- Death
- 5
- Total
- 5
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.