MAMMOTOME REOLVE DUAL VACUUM ASSISTED BIOPSY (VAB) SYSTEM— 510(k) K123259
Substantially EquivalentDevicor Medical Products, Inc.
FDA 510(k) clearance K123259 for MAMMOTOME REOLVE DUAL VACUUM ASSISTED BIOPSY (VAB) SYSTEM, Substantially Equivalent on 2012-11-15. Applicant: Devicor Medical Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Devicor Medical Products, 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
- Cincinnati, OH, US
Recent devices under product code KNW
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view all- K260365 — Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Control Module +5 more
- K253761 — HydroMARK Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape)
- K243095 — Mammotome AutoCore Single Insertion Core Biopsy System
- K240527 — HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6)
- K232615 — LumiMARK Biopsy Site Marker (LM0215T (Tulip Shape)) +2 more
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 →
Recalls naming K123259
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123259.
Data sourced from openFDA. This site is unofficial and independent of the FDA.