510(k) clearances

Marrow Marxman

Medimetrix, LLC · Gastroenterology, Urology

K260572Substantially EquivalentTraditionalKNW
Open FDA's page for this record
Third party flag
N
City
Germantown
Advisory committee description
Gastroenterology, Urology
Address 1
3012 Centre Oak Way
Address 2
Suite 102
Statement or summary
Summary
Product code
KNW
Zip code
38138
Applicant
Medimetrix, LLC
Decision date
2026-08-04
Decision code
SESE
Country code
US
Device name
Marrow Marxman
Advisory committee
GU
Contact
Brian Austin
K number
K260572
State
TN
Date received
2026-02-19
Review advisory committee
SU
Postal code
38138
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Instrument, Biopsy
Medical specialty description
Gastroenterology, Urology
Regulation number
876.1075
Device class
2
Registration number
3018507299, 1224960, 3021023752, 3005580113, 3017210488, 3007137598, 1219114, 1526711, 3030626857, 3008262715, 3038611181, 3010097171, 1835568, 9617592, 3010220595, 3016844398, 3006849754, 2029275, 3004111573, 3010041511, 1644312, 9617616, 1820334, 3012447612, 2648623, 3004122598, 3004774118, 3030733800, 3015980719, 1419411, 1643817, 3006788678, 3033858858, 2020394, 1048735, 1319660, 1450662, 3008773560, 3015309643, 3012470322 +166 more
FEI number
3018507299, 3021023752, 3007019930, 3005580113, 3017210488, 3007137598, 1219114, 1526711, 3030626857, 3008262715, 3038611181, 3010097171, 3003056094, 3010220595, 3016844398, 3000215205, 3006849754, 3010041511, 3004111573, 3002827704, 3002808445, 3012447612, 1820334, 2648623, 3004122598, 3030733800, 3015980719, 1643817, 3006788678, 3033858858, 2020394, 1048735, 1450662, 3008773560, 3015309643, 3012470322, 3008002452, 3012495575, 3007513241, 3010082909 +166 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.