Data / Medical devices / Australia / Trewavis Surgical Instruments Pty Ltd.
Trewavis Surgical Instruments Pty Ltd.: FDA-registered device maker in Bayswater Victoria, Australia, 1 510(k) clearance
Trewavis Surgical Instruments Pty Ltd. is registered with the FDA (registration 9680770) in Bayswater Victoria, Australia. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 27, 1990. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9680770
- FEI number
- 3006795395
- Address
- 21 Michellan Court, Bayswater Victoria, Australia, 3153
- Owner or operator
- TREWAVIS SURGICAL INSTRUMENTS PTY LTD (9011291)
- Roles
- Manufacturer
- First device listed
- November 20, 2007
- Registered through
- 2027
- Brand names listed
- JC Medical, KEON COHEN RETRACTOR, Rectal Suction Biopsy Tool Sterile Single Use, SBT 200, SBT-200, Sterile Single Use Rectal Suction Biopsy Tool, Sterile Single-Use Rectal Suction Biopsy System, Trewavis Surgical
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Forceps, Biopsy, Non-Electric | FCL | 1 | Manufacturer | accessdata.fda.gov |
| Instrument, Biopsy, Suction | FCK | 2 | Manufacturer | accessdata.fda.gov |
| Retractor, Self-Retaining | FFO | 1 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| July 27, 1990 | K902097 | MODEL TR RECTAL SUCTION BIOPSY TUBE | FCK | Substantially Equivalent | Medical Measurements, Inc. | accessdata.fda.gov |
Compare with other makers
Updated July 27, 1990. 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.