BIOPSY SCIENCES, LLC. MAXI-CELL BIOPSY NEEDLES— 510(k) K021847
Substantially EquivalentBiopsy Sciences, LLC
FDA 510(k) clearance K021847 for BIOPSY SCIENCES, LLC. MAXI-CELL BIOPSY NEEDLES, Substantially Equivalent on 2002-09-03. Applicant: Biopsy Sciences, LLC. Device class: 2.
Clearance details
- Applicant
- Biopsy Sciences, LLC
- Product code
- Code FCG
- Device class
- Class 2
- Regulation
- 21 CFR 876.1075
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Yorba Linda, CA, US
Recent devices under product code FCG
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- K083006 — BIOPSY SCIENCES, INC., HYDROMARK BREAST BIOPSY SITE MARKER
- K060769 — HYDROMARK BIOPSY SITE MARKER
Adverse events under product code FCG
product code FCG- Death
- 13
- Injury
- 576
- Malfunction
- 1,966
- Total
- 2,555
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.