510(k) K002803 ยท FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
THE O'NEIL STERILE FIELD URINARY CATHETER KIT
| Applicant | Go Medical Industries Pty. , Ltd., Subiaco, Perth, AU |
| Decision | Substantially Equivalent, Dec 27, 2000 |
| Received | Sep 8, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002803
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 21, 2011 | Go Medical Industries Pty., Ltd. O'Neil Sterile Field Intermittent Urinary Catheter Kit labeled in mart:"***ORIGINAL CLOSED SYSTEM BY DR O'NEIL O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER KIT WITH IODINE SWABSTICKS (3)*** REF: Terminated |
FCM | None listed |
| Oct 21, 2011 | Go Medical Industries Pty., Ltd. O'Neil Sterile Field Intermittent Urinary Catheter Kit labeled in mart:"***ORIGINAL CLOSED SYSTEM BY DR O'NEIL O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER KIT WITH IODINE SWABSTICKS (3)*** REF: Terminated |
FCM | None listed |
| Oct 21, 2011 | Go Medical Industries Pty., Ltd. O'Neil Sterile Field Intermittent Urinary Catheter Kit labeled in mart:"***ORIGINAL CLOSED SYSTEM BY DR O'NEIL O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER KIT WITH IODINE SWABSTICKS (3)*** REF: Terminated |
FCM | None listed |
| Oct 21, 2011 | Go Medical Industries Pty., Ltd. O'Neil Sterile Field Intermittent Urinary Catheter Kit labeled in mart:"***ORIGINAL CLOSED SYSTEM BY DR O'NEIL O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER KIT WITH IODINE SWABSTICKS (3)*** REF: Terminated |
FCM | None listed |
| Oct 21, 2011 | Go Medical Industries Pty., Ltd. O'Neil Sterile Field Intermittent Urinary Catheter Kit labeled in mart:"***ORIGINAL CLOSED SYSTEM BY DR O'NEIL O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER KIT WITH IODINE SWABSTICKS (3)*** REF: Terminated |
FCM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.