Atlas FDA

THE O'NEIL STERILE FIELD URINARY CATHETER KIT

FDA 510(k) clearance K002803 · decided 2000-12-27

Clearance details

K-number
K002803
Device name
THE O'NEIL STERILE FIELD URINARY CATHETER KIT
Applicant
Go Medical Industries Pty. , Ltd.
Decision
Substantially Equivalent
Date received
2000-09-08
Decision date
2000-12-27
Days to decision
110 days
Clearance type
Traditional
Product code
FCM
Device class
2
Regulation number
876.5130
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Subiaco, Perth, AU
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Go Medical Industries Pty.

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit (K254076)C.R. Bard, Inc.2026-05-29
Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14C (K250891)Convatec Limited2025-06-06
Self-Cath Closed System (K223821)Coloplast2023-08-02
AMSELF CLOSED CATHETERIZATION SYSTEM (K082831)Amsino International, Inc.2008-10-23
SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM (K070939)Coloplast Manufacturing Us, LLC2007-06-01
GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT (K070048)Marian Medical, Inc.2007-03-15
AMSURE URETHRAL CATHETERIZATION TRAY (K030712)Amsino International, Inc.2003-05-23
AMSURE FOLEY INSERTION TRAY (K030664)Amsino International, Inc.2003-05-23
THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS (K011055)Go Medical Industries Pty. , Ltd.2001-06-06
RUSCH MMG/O'NEIL CATHETER (K010420)Rusch, Inc.2001-05-09
MENTOR SELF-CATH CLOSED SYSTEM (K003873)Mentor Corp.2001-03-29
SELF CATH SET/SAFETY CATH (K983010)Rusch Intl.1999-02-12

Recalls involving this device

RecordFirmDate
O'Neil Sterile Field Intermittent Urinary Catheter Kit labeled in mart:"***ORIGINAL CLOSED recall (Z-0084-2012)Go Medical Industries Pty., Ltd.2011-10-21
O'Neil Sterile Field Intermittent Urinary Catheter Kit labeled in mart:"***ORIGINAL CLOSED recall (Z-0085-2012)Go Medical Industries Pty., Ltd.2011-10-21
O'Neil Sterile Field Intermittent Urinary Catheter Kit labeled in mart:"***ORIGINAL CLOSED recall (Z-0086-2012)Go Medical Industries Pty., Ltd.2011-10-21
O'Neil Sterile Field Intermittent Urinary Catheter Kit labeled in mart:"***ORIGINAL CLOSED recall (Z-0087-2012)Go Medical Industries Pty., Ltd.2011-10-21
O'Neil Sterile Field Intermittent Urinary Catheter Kit labeled in mart:"***ORIGINAL CLOSED recall (Z-0088-2012)Go Medical Industries Pty., Ltd.2011-10-21