Marrow Marxman— 510(k) K260572
Substantially EquivalentMedimetrix, LLC
FDA 510(k) clearance K260572 for Marrow Marxman, Substantially Equivalent on 2026-08-04. Applicant: Medimetrix, LLC. Device class: 2.
Summary
Medimetrix's Marrow Marxman is filed under product code KNW, biopsy instruments. The record doesn't describe the device beyond its name and that code.
Class II, 21 CFR 876.1075. The General and Plastic Surgery review panel handled it as a Traditional 510(k), though the record lists Gastroenterology and Urology as the classification panel.
Medimetrix filed from Germantown, Tennessee. Review took 166 calendar days (February 19 to August 4, 2026), ending in a substantially equivalent decision.
Clearance details
- Applicant
- Medimetrix, LLC
- Product code
- Product 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
- Germantown, TN, US
Recent devices under product code KNW
view all- K260517 — Automatic Core Biopsy Instrument
- K262571 — EnCor EnCompass Breast Biopsy and Tissue Removal System
- K262792 — Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)
- K261196 — Promisemed VeriEcto Automatic Biopsy Needles
- K260365 — Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Control Module +5 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.