SENORX BIOPSY DEVICE II— 510(k) K040842

Name: FDA 510(k) clearance K040842
Creator: U.S. Food and Drug Administration
Published: 2004-04-30

Substantially Equivalent

Senorx, Inc.

FDA 510(k) clearance K040842 for SENORX BIOPSY DEVICE II, Substantially Equivalent on 2004-04-30. Applicant: Senorx, Inc.. Device class: 2.

Clearance details

Applicant: Senorx, Inc.
Product code: Code KNW
Device class: Class 2
Regulation: 21 CFR 876.1075
Advisory panel: Gastroenterology, Urology
Date received: 2004-04-01
Decision date: 2004-04-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Aliso Viejo, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KNW

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K262571 — EnCor EnCompass Breast Biopsy and Tissue Removal System2026-08-14
K262792 — Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)2026-08-12
K260572 — Marrow Marxman2026-08-04
K261196 — Promisemed VeriEcto Automatic Biopsy Needles2026-05-12

More clearances from Senorx, Inc.

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K233220 — EnCor EnspireBreast Biopsy System (E4115, E4230) +4 more2023-10-27
K210654 — EnCor Breast Biopsy Probe with Rinse Tube2021-03-31
K161805 — EnCor MRI Introducer Set, EnCor Probe Introducer2016-07-19
K131654 — STARCHMARK BREAST TISSUE MARKER; STARCHMARK ULTRACOR BREAST TISSUE MARKER2013-06-27
K093512 — ENCOR BREAST BIOPSY SYSTEM2009-11-20

Adverse events under product code KNW

product code KNW

Death: 9
Injury: 965
Malfunction: 10,444
Other: 3
Total: 11,421

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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 K040842

K-number listed on FDA's recall record

Z-1431-2020 — Bard Biopsy EnCor Probe, Stereotactic/Ultrasound 7G, REF number ECP017G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.Class II·Terminated·Bard Peripheral Vascular Inc·20200103
Z-1432-2020 — Bard Biopsy EnCor Probe, MRI, 7G Trocar Tip, REF number ECPMR017G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.Class II·Terminated·Bard Peripheral Vascular Inc·20200103
Z-1433-2020 — Bard Biopsy EnCor Probe, MRI, 10G Trocar Tip, REF number ECPMR0110G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.Class II·Terminated·Bard Peripheral Vascular Inc·20200103
Z-1434-2020 — Bard Biopsy EnCor Probe, MRI, 10G Blunt Tip, REF number ECPMR0110GBT, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.Class II·Terminated·Bard Peripheral Vascular Inc·20200103
Z-2209-2019 — EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 10G - REF ECP0110G. Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.Class II·Terminated·Bard Peripheral Vascular Inc·20190502
Z-2210-2019 — EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF numbers 10GV Upright (Vertical) - REF ECP0110GV. Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.Class II·Terminated·Bard Peripheral Vascular Inc·20190502
Z-2211-2019 — EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 12G - REF ECP0112G. Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.Class II·Terminated·Bard Peripheral Vascular Inc·20190502
Z-2212-2019 — EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF numbers 12GV Upright (Vertical) - REF ECP0112GV. Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.Class II·Terminated·Bard Peripheral Vascular Inc·20190502
Z-2213-2019 — EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 7G - REF ECP017G.Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.Class II·Terminated·Bard Peripheral Vascular Inc·20190502
Z-2214-2019 — EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 7GV Upright (Vertical) - REF ECP017GV. Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.Class II·Terminated·Bard Peripheral Vascular Inc·20190502

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K040842.

Data sourced from openFDA. This site is unofficial and independent of the FDA.