AVOCET ACUSURE SYSTEM— 510(k) K991286

Substantially Equivalent

Avocet Medical, Inc.

FDA 510(k) clearance K991286 for AVOCET ACUSURE SYSTEM, Substantially Equivalent on 1999-11-18. Applicant: Avocet Medical, Inc..

Clearance details

Applicant: Avocet Medical, Inc.
Product code: Code GJS
Advisory panel: Hematology
Date received: 1999-04-15
Decision date: 1999-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GJS

product code GJS

Death: 4
Injury: 229
Malfunction: 4,852
Total: 5,085

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.