Mammotome revolve Dual Vacuum Assist Biopsy System— 510(k) K152989
Substantially EquivalentDevicor Medical Products, Inc.
FDA 510(k) clearance K152989 for Mammotome revolve Dual Vacuum Assist Biopsy System, Substantially Equivalent on 2016-02-25. 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
view allMore clearances from Devicor Medical Products, Inc.
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 K152989
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 K152989.
Data sourced from openFDA. This site is unofficial and independent of the FDA.