Atlas FDA

MEDLINE RED RUBBER URETHRAL CATHETER

FDA 510(k) clearance K092250 · decided 2010-01-21

Clearance details

K-number
K092250
Device name
MEDLINE RED RUBBER URETHRAL CATHETER
Applicant
Medline Industries, Inc.
Decision
Substantially Equivalent
Date received
2009-07-28
Decision date
2010-01-21
Days to decision
177 days
Clearance type
Traditional
Product code
EYB
Device class
2
Regulation number
876.5130
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Mundelein, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
MEDLINE Urethral Catheter, Red Rubber Latex, Medline Product Number/SKU (REF), French size recall (Z-2479-2026)Medline Industries, LP2026-06-17
MEDLINE Medical Procedure Kits labeled as: CATH 22F ROBINSON STRL 5'S PK, Medline Kit Numb recall (Z-2492-2026)Medline Industries, LP2026-06-17