Data / Medical devices / Australia / Go Medical Industries Pty. Ltd.
Go Medical Industries Pty. Ltd.: FDA-registered device maker in SUBIACO Western Australia, Australia, 5 510(k) clearances
Go Medical Industries Pty. Ltd. is registered with the FDA (registration 9611004) in SUBIACO Western Australia, Australia. It lists 6 device types. The FDA files 5 510(k) clearances under its listings, the newest dated December 23, 1999. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 9611004
- FEI number
- 3002807099
- Address
- 200 Churchill Avenue, SUBIACO Western Australia, Australia, 6008
- Owner or operator
- GO MEDICAL INDUSTRIES PTY. LTD. (8020024)
- Roles
- Specification developer
- First device listed
- February 4, 2008
- Registered through
- 2026
- Brand names listed
- Amnicot, Catherter, Urological, O'Neil Nasal Spray, O'Neil Sterile Field Urinary Catheter, Springfusor, Flow Control Tubing, V-Sets
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Amniotome | HGE | 1 | Specification developer | accessdata.fda.gov |
| Catheter, Urethral | GBM | 2 | Specification developer | accessdata.fda.gov |
| Catheter, Urological | KOD | 2 | Specification developer | accessdata.fda.gov |
| Nasal Spray, Ent Delivery | KCO | 1 | Specification developer | accessdata.fda.gov |
| Pump, Infusion | FRN | 2 | Specification developer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 23, 1999 | K993651 | O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER | GBM | Substantially Equivalent | Sc Hennig Enterprises Europe Srl | accessdata.fda.gov |
| November 2, 1993 | K910007 | SPRINGFUSOR 10R | FRN | Substantially Equivalent | Go Medical Industries Pty. , Ltd. | accessdata.fda.gov |
| October 4, 1990 | K900336 | V SET | FPA | Substantially Equivalent | Go Medical Industries Pty. , Ltd. | accessdata.fda.gov |
| September 12, 1989 | K890400 | MODIFIED URINARY CATHETER INTRODUCER (UCI) | KOD | Substantially Equivalent | Go Medical Industries Pty. , Ltd. | accessdata.fda.gov |
| April 15, 1985 | K850758 | AMNIGLOVE & AMNICOT | HGE | Substantially Equivalent | Go Medical Industries Pty. , Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 3, 2011 | 59892 | Not yet classified | Terminated | 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: ONSM 14KPES SIZE:14 | O'Neil Sterile Field Intermittent Urinary Catheter Kits With Povidone Iodine Swabsticks are being recalled due to a recall on the Triad Povidone Iodine Swabsticks contained within the kit. H&P Industries are recalling the Triad Povidone Iodine Swabsticks because it was determined that the swabsticks were manufactured without having a system for microbial tes | accessdata.fda.gov |
Compare with other makers
- All makers of Pump, Infusion
- All makers of Nasal Spray, Ent Delivery
- All makers of Set, Administration, Intravascular
- All makers of Catheter, Urethral
- All makers of Amniotome
- All makers of Catheter, Urological
Updated October 21, 2011. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.