510(k) K210782— Tablo Cartridge

Substantially Equivalent

Outset Medical, Inc.

Clearance details

Applicant: Outset Medical, Inc.
Product code: Code FJK
Advisory panel: Gastroenterology, Urology
Date received: 2021-03-16
Decision date: 2021-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Adverse events under product code FJK

product code FJK

Death: 52
Malfunction: 3,430
Total: 3,482

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.