ENCOR BREAST BIOPSY SYSTEM— 510(k) K093512
Substantially EquivalentSenorx, Inc.
FDA 510(k) clearance K093512 for ENCOR BREAST BIOPSY SYSTEM, Substantially Equivalent on 2009-11-20. 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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code KNW
view allMore clearances from Senorx, Inc.
view all- K233220 — EnCor EnspireBreast Biopsy System (E4115, E4230) +4 more
- K210654 — EnCor Breast Biopsy Probe with Rinse Tube
- K161805 — EnCor MRI Introducer Set, EnCor Probe Introducer
- K131654 — STARCHMARK BREAST TISSUE MARKER; STARCHMARK ULTRACOR BREAST TISSUE MARKER
- K092323 — CONTURA CAVITY MAINTENANCE CATHETER
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, 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.