IRRIGATION CATHETER— 510(k) K780788

Substantially Equivalent

Shiley, Inc.

FDA 510(k) clearance K780788 for IRRIGATION CATHETER, Substantially Equivalent on 1978-06-22. Applicant: Shiley, Inc..

Clearance details

Applicant: Shiley, Inc.
Product code: Code GBX
Advisory panel: General, Plastic Surgery
Date received: 1978-05-15
Decision date: 1978-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GBX

product code GBX

Death: 16
Injury: 583
Malfunction: 3,578
Other: 1
Total: 4,178

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.