DIDECO-SHILEY PREASSEMBLED SURGICAL WASH SET— 510(k) K872161

Substantially Equivalent

Shiley, Inc.

FDA 510(k) clearance K872161 for DIDECO-SHILEY PREASSEMBLED SURGICAL WASH SET, Substantially Equivalent on 1987-08-12. Applicant: Shiley, Inc..

Clearance details

Applicant: Shiley, Inc.
Product code: Code DTL
Advisory panel: Cardiovascular
Date received: 1987-06-04
Decision date: 1987-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DTL

product code DTL

Malfunction: 770
Total: 770

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.