BIOPSY SCIENCES, LLC, LUNG BIOPSY SITE MARKER— 510(k) K041331
Substantially EquivalentBiopsy Sciences, LLC
FDA 510(k) clearance K041331 for BIOPSY SCIENCES, LLC, LUNG BIOPSY SITE MARKER, Substantially Equivalent on 2004-06-15. Applicant: Biopsy Sciences, LLC. Device class: 2.
Clearance details
- Applicant
- Biopsy Sciences, LLC
- Product code
- Code GDW
- Device class
- Class 2
- Regulation
- 21 CFR 878.4750
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Yorba Linda, CA, US
Recent devices under product code GDW
view allMore clearances from Biopsy Sciences, LLC
view all- K130537 — BIOPSY SCIENCES LLC HYDROMARK BREAST BIOPSY SITE MARKER
- K121113 — BIOPSY SCIENCES, INC. HYDROMARK BREST BIOSY SITE MARKER
- K090501 — BIOPSY SCIENCES HYDROMARK BREAST BIOPSY SITE MARKER, MODELS 4005-02-15-T1, 4005-02-15-S1, 4005-03-15-T1, 4005-03-15-S1
- K083006 — BIOPSY SCIENCES, INC., HYDROMARK BREAST BIOPSY SITE MARKER
- K060769 — HYDROMARK BIOPSY SITE MARKER
Adverse events under product code GDW
product code GDW- Death
- 450
- Injury
- 12,684
- Malfunction
- 68,730
- Other
- 6
- Total
- 81,870
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.