Bard Mission Disposable Core Biopsy Instrument— 510(k) K171953
Substantially EquivalentBard Peripheral Vascular, Inc.
FDA 510(k) clearance K171953 for Bard Mission Disposable Core Biopsy Instrument, Substantially Equivalent on 2017-09-14. Applicant: Bard Peripheral Vascular, Inc.. Device class: 2.
Clearance details
- Applicant
- Bard Peripheral Vascular, Inc.
- Product code
- Code KNW
- Device class
- Class 2
- Regulation
- 21 CFR 876.1075
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tempe, AZ, US
Recent devices under product code KNW
view allMore clearances from Bard Peripheral Vascular, Inc.
view allAdverse events under product code KNW
product code KNW- Death
- 9
- Injury
- 965
- Malfunction
- 10,444
- Other
- 3
- Total
- 11,421
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 K171953
K-number listed on FDA's recall record- Z-0643-2024 — Bard Mission Disposable Core Biopsy Instrument Kit (REF/Name): 1410MSK/ Mission Kit 14G x 10CM; 1416MSK/ Mission Kit 14G x 16CM; 1610MSK/ Mission Kit 16G x 10CM; 1616MSK/ Mission Kit 16G x 16CM; 1810MSK/ Mission Kit 18G x 10CM; 1816MSK/ Mission Kit 18G x 16CM; 1820MSK/ Mission Kit 18G x 20CM; 1825MSK/ Mission Kit 18G x 25CM; 2010MSK/ Mission Kit 20G x 10CM; 2016MSK/ Mission Kit 20G x 16CM; 2020MSK/ Mission Kit 20G x 20CM
- Z-1564-2023 — Bard Mission Disposable Core Biopsy Instrument Kit: REF: 2010MSK, 20G x 10CM; REF: 2016MSK, 20G x 16CM
- Z-1260-2023 — Bard Mission Disposable Core Biopsy Instrument Kit: 16G x 10CM, REF: 1610MSK; 18G x 16CM, REF: 1816MSK
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K171953.
Data sourced from openFDA. This site is unofficial and independent of the FDA.