Minimally Invasive Prostate Surgery Navigation System— 510(k) K221499

Substantially Equivalent

Augment Intelligent Medical System (China) Co., Ltd.

FDA 510(k) clearance K221499 for Minimally Invasive Prostate Surgery Navigation System, Substantially Equivalent on 2022-11-22. Applicant: Augment Intelligent Medical System (China) Co., Ltd..

Clearance details

Applicant: Augment Intelligent Medical System (China) Co., Ltd.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2022-05-23
Decision date: 2022-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nanjing, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.