K221499

Substantially Equivalent

Minimally Invasive Prostate Surgery Navigation System

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

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.