COAXIAL BIOPSY NEEDLE— 510(k) K936194
Substantially EquivalentBard Gynecology and Radiology
FDA 510(k) clearance K936194 for COAXIAL BIOPSY NEEDLE, Substantially Equivalent on 1994-03-22. Applicant: Bard Gynecology and Radiology. Device class: 2.
Clearance details
- Applicant
- Bard Gynecology and Radiology
- 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
- Covington, GA, US
Recent devices under product code FCG
view allAdverse 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 →
Recalls naming K936194
K-number listed on FDA's recall record- Z-2547-2016 — Bard TruGuide Disposable Coaxial Biopsy Needle Mixed Product Part Number C1816B The TruGuide Disposable Coaxial Biopsy Needles are intended for use as a guiding needle in obtaining core biopsy samples from soft tissue such as liver, kidney, spleen, lymph nodes and various soft tissue lesions.
- Z-1396-2016 — Bard TruGuide Disposable Coaxial Biopsy Needle Product Usage: The TruGuide Disposable Coaxial Biopsy Needles are intended for use as a guiding needle in obtaining core biopsy samples from soft tissue such as liver, kidney, spleen, lymph nodes and various soft tissue lesions.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K936194.
Data sourced from openFDA. This site is unofficial and independent of the FDA.