EDWARDS DISPOSABLE ARTHROSCOPY CANNULA— 510(k) K884301

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K884301 for EDWARDS DISPOSABLE ARTHROSCOPY CANNULA, Substantially Equivalent on 1989-03-13. Applicant: Baxter Healthcare Corp.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 1988-10-13
Decision date: 1989-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

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.