Atlas FDA

RUSCH MMG/O'NEIL CATHETER

FDA 510(k) clearance K010420 · decided 2001-05-09

Clearance details

K-number
K010420
Device name
RUSCH MMG/O'NEIL CATHETER
Applicant
Rusch, Inc.
Decision
Substantially Equivalent
Date received
2001-02-12
Decision date
2001-05-09
Days to decision
86 days
Clearance type
Traditional
Product code
FCM
Device class
2
Regulation number
876.5130
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Duluth, GA, US
Third-party review
No
Expedited review
No

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THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS (K011055)Go Medical Industries Pty. , Ltd.2001-06-06
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Recalls involving this device

RecordFirmDate
Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit, 14 Fr (4.7 recall (Z-0227-2023)TELEFLEX LLC2022-11-11
Rusch/MMG Urinary Catheterization System, 14 Fr; the single use sterile kit contains a Rus recall (Z-1083-05)Teleflex Medical2005-08-04