Data / Medical devices / Singapore / Biobot Surgical Pte. Ltd.
Biobot Surgical Pte. Ltd.: FDA-registered device maker in Singapore South West, Singapore, 6 510(k) clearances
Biobot Surgical Pte. Ltd. is registered with the FDA (registration 3008548323) in Singapore South West, Singapore. It lists 4 device types. The FDA files 6 510(k) clearances under its listings, the newest dated December 21, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008548323
- Address
- 79 Ayer Rajah Crescent, #04-05, Singapore South West, Singapore, 139955
- Owner or operator
- Biobot Surgical Pte. Ltd. (10046782)
- Roles
- Manufacturer
- First device listed
- May 12, 2014
- Registered through
- 2026
- Brand names listed
- iSR'obot Biopsy Kit, iSR'obot MRI-US Fusion, iSR'obot Mona Lisa, iSR'obot Mona Lisa 1, iSR'obot Mona Lisa 2
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Biopsy Needle Guide Kit | OIJ | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Manufacturer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | 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 |
|---|---|---|---|---|---|---|
| December 21, 2023 | K232320 | iSR`obot Mona Lisa 2.0 | IYO | Substantially Equivalent | Biobot Surgical Pte., Ltd. | accessdata.fda.gov |
| December 22, 2021 | K213411 | iSRobot Mona Lisa 2.0 | IYO | Substantially Equivalent | Biobot Surgical Pte., Ltd. | accessdata.fda.gov |
| July 8, 2021 | K203659 | iSR'obot Mona Lisa 1.0 | IYO | Substantially Equivalent | Biobot Surgical Pte., Ltd. | accessdata.fda.gov |
| May 16, 2017 | K163502 | iSR'obot Biopsy Kit | ITX | Substantially Equivalent | Biobot Surgical Pte., Ltd. | accessdata.fda.gov |
| October 6, 2016 | K161109 | iSR'obot MRI-US Fusion | LLZ | Substantially Equivalent | Biobot Surgical Pte., Ltd. | accessdata.fda.gov |
| June 7, 2013 | K130944 | ISR'OBOT MONA LISA | IYO | Substantially Equivalent | Biobot Surgical Pte., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of System, Image Processing, Radiological
- All makers of Biopsy Needle Guide Kit
Updated December 21, 2023. 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.