# Biobot Surgical Pte., Ltd.

- Location (FDA's records): Singapore, SG
- FDA decisions: 7 (2011–2023): 7 510(k) clearances
- Product codes: IYO (5), LLZ (1), ITX (1)
- 510(k) review time since 2016: median 153 days, against 90 for FDA's reviews in the same codes and years (1 of 5 faster)
- Predicates its devices cite: 11 (6 its own); citations of its devices by later devices: 6 (6 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Envisioneering, LLC: 3 (https://510kreport.com/company/envisioneering)
- Igt, LLC Dba Eigen: 1 (https://510kreport.com/company/igt-dba-eigen)
- CIVCO Medical Instruments Co., Inc.: 1 (https://510kreport.com/company/civco-medical-instruments)

## Its most-cited devices
- K213411: iSR’obot Mona Lisa 2.0 (2021), cited by 1
- K161109: iSR'obot MRI-US Fusion (2016), cited by 1
- K130944: Isr'obot Mona Lisa (2013), cited by 1
- K111347: Isrobot Mona Lisa (2011), cited by 1
- K203659: iSR'obot Mona Lisa 1.0 (2021), cited by 1
- K163502: iSR'obot Biopsy Kit (2017), cited by 1

## Recent decisions
- K232320: iSR`obot Mona Lisa 2.0 (Dec 21, 2023)
- K213411: iSR’obot Mona Lisa 2.0 (Dec 22, 2021)
- K203659: iSR'obot Mona Lisa 1.0 (Jul 8, 2021)
- K163502: iSR'obot Biopsy Kit (May 16, 2017)
- K161109: iSR'obot MRI-US Fusion (Oct 6, 2016)
- K130944: Isr'obot Mona Lisa (Jun 7, 2013)
- K111347: Isrobot Mona Lisa (Aug 12, 2011)

Source page: https://510kreport.com/company/biobot-surgical