ISR'OBOT MONA LISA— 510(k) K130944

Substantially Equivalent

Biobot Surgical Pte., Ltd.

FDA 510(k) clearance K130944 for ISR'OBOT MONA LISA, Substantially Equivalent on 2013-06-07. Applicant: Biobot Surgical Pte., Ltd..

Clearance details

Applicant: Biobot Surgical Pte., Ltd.
Product code: Code IYO
Advisory panel: Radiology
Date received: 2013-04-04
Decision date: 2013-06-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Singapore, SG

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.