Data / Medical devices / Australia / The O R Company Pty Ltd
The O R Company Pty Ltd: FDA-registered device maker in Cheltenham Victoria, Australia, 5 510(k) clearances
The O R Company Pty Ltd is registered with the FDA (registration 3008254127) in Cheltenham Victoria, Australia. It lists 11 device types. The FDA files 5 510(k) clearances under its listings, the newest dated March 31, 2022. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3008254127
- Address
- 4/47 Wangara Road, Cheltenham Victoria, Australia, 3192
- Owner or operator
- The O R Company Pty Ltd (10031641)
- Roles
- Exporter to the US, Foreign private label distributor, Specification developer
- First device listed
- February 22, 2010
- Registered through
- 2026
- Brand names listed
- Occluder Balloon
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Cleaning Brushes, For Endoscope | MNL | 1 | Exporter to the US, Foreign private label distributor, Specification developer | accessdata.fda.gov |
| Anti Fog Solution And Accessories, Endoscopy | OCT | 2 | Exporter to the US, Foreign private label distributor, Specification developer | accessdata.fda.gov |
| Cannula, Manipulator/Injector, Uterine | LKF | 2 | Exporter to the US, Foreign private label distributor, Specification developer | accessdata.fda.gov |
| Culdoscope (And Accessories) | HEW | 2 | Exporter to the US, Foreign private label distributor, Specification developer | accessdata.fda.gov |
| Instrument, Ligature Passing And Knot Tying | HCF | 1 | Exporter to the US, Foreign private label distributor, Specification developer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Exporter to the US, Foreign private label distributor, Specification developer | accessdata.fda.gov |
| Insufflator, Laparoscopic | HIF | 2 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Laparoscopic Accessories, Gynecologic | NWV | 1 | Exporter to the US, Foreign private label distributor, Specification developer | accessdata.fda.gov |
| Pack, Hot Or Cold, Disposable | IMD | 1 | Exporter to the US, Foreign private label distributor, Specification developer | accessdata.fda.gov |
| Retainer, Surgical | GCZ | 1 | Exporter to the US, Foreign private label distributor, Specification developer | accessdata.fda.gov |
| Tubing/Tubing With Filter, Insufflation, Laparoscopic | NKC | 1 | Exporter to the US, Foreign private label distributor | 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 |
|---|---|---|---|---|---|---|
| March 31, 2022 | K220202 | Uterine ElevatOR PRO with OccludOR Balloon | LKF | Substantially Equivalent | The O R Company Pty, Ltd. | accessdata.fda.gov |
| January 10, 2022 | K212505 | DUMI ManipulatOR | LKF | Substantially Equivalent | The O R Company Pty, Ltd. | accessdata.fda.gov |
| January 22, 2019 | K181887 | AMD Anti-Fog Solution | OCT | Substantially Equivalent | Advanced Medical Design Co., Ltd. | accessdata.fda.gov |
| December 19, 2014 | K142700 | InsufflatOR Needle | HIF | Substantially Equivalent | Gynetech Pty. , Ltd. | accessdata.fda.gov |
| September 2, 2005 | K051594 | MCCARTNEY ACCESS TUBE | HEW | Substantially Equivalent | Gynetech Pty. , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Cannula, Manipulator/Injector, Uterine
- All makers of Pack, Hot Or Cold, Disposable
- All makers of Laparoscopic Accessories, Gynecologic
- All makers of Accessories, Cleaning Brushes, For Endoscope
- All makers of Anti Fog Solution And Accessories, Endoscopy
- All makers of Tubing/Tubing With Filter, Insufflation, Laparoscopic
Updated March 31, 2022. 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.