510(k) K011055
- Device
- THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS
- Applicant
- GO MEDICAL INDUSTRIES PTY. LTD.
- 510(k) number
- K011055
- Product code
- FCM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-06-06
- Date received
- 2001-04-06
- Regulation
- 876.5130
- Classification name
- Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit)
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- GEORGE O'NEIL
- Address
- 200 Churchill Ave. Subiaco, Perth AU 6008 6008
FDA Registration Numbers#
- 9680787
- 3013188547
- 1055236
- 2320961
- 3006673317
- 1018233
- 1650927
- 3011137372
- 8040607
- 3002993863
- 3012445205
- 3004727093
- 3011987967
- 9612030
- 2011171
- 3017937889
- 3005669815
- 1928237
- 9610849
- 3022518300
- 3015142802
- 3008806809
- 3006430057
- 3011707784
- 9610694
- 1420054
- 3014421917
- 1647149
- 3014656749
- 3015173212
- 9611590
- 1043214
- 3004111573
- 3007185216
- 8040412
- 2032112
- 3006542380
- 3006082230
- 1423537
- 3009609358
- 3004122598
- 3018116884
- 2029015
- 3010220595
- 3017961114
- 3015176887
- 1480288
- 2320762
- 3008191244
- 3030087693
- 1054241
- 2648727
- 3014404707
- 3004365956
- 1921846
- 3005012805
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FCM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254076 | BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit | C.R. Bard, Inc. | 2026-05-29 |
| K250891 | 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 | Convatec Limited | 2025-06-06 |
| K223821 | Self-Cath Closed System | Coloplast | 2023-08-02 |
| K082831 | AMSELF CLOSED CATHETERIZATION SYSTEM | Amsino International, Inc. | 2008-10-23 |
| K070939 | SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM | Coloplast Manufacturing Us, LLC | 2007-06-01 |
| K070048 | GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT | Marian Medical, Inc. | 2007-03-15 |
| K030664 | AMSURE FOLEY INSERTION TRAY | Amsino International, Inc. | 2003-05-23 |
| K030712 | AMSURE URETHRAL CATHETERIZATION TRAY | Amsino International, Inc. | 2003-05-23 |
| K010420 | RUSCH MMG/O'NEIL CATHETER | Rusch, Inc. | 2001-05-09 |
| K003873 | MENTOR SELF-CATH CLOSED SYSTEM | Mentor Corp. | 2001-03-29 |
| K002803 | THE O'NEIL STERILE FIELD URINARY CATHETER KIT | Go Medical Industries Pty. , Ltd. | 2000-12-27 |
| K983010 | SELF CATH SET/SAFETY CATH | Rusch Intl. | 1999-02-12 |
| K963993 | RUSCH SIMPLASTIC FOLEY CATHETERIZATION SET | Rusch, Inc. | 1996-12-17 |
| K962254 | NHMC URETHRAL CATHETERIZATION TRAY | National Healthcare Mfg. Corp. | 1996-07-29 |
| K962073 | URETHRAL CATHETERIZATION TRAY/UNIVERSAL URETHRAL CATH TRAY | Continental Medical Laboratories, Inc. | 1996-06-21 |
Legacy Summary#
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FDA Review#
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