CLOSED CHEST DRAINAGE SET— 510(k) K871873

Substantially Equivalent

Gish Biomedical, Inc.

FDA 510(k) clearance K871873 for CLOSED CHEST DRAINAGE SET, Substantially Equivalent on 1987-07-09. Applicant: Gish Biomedical, Inc..

Clearance details

Applicant: Gish Biomedical, Inc.
Product code: Code LRO
Advisory panel: General, Plastic Surgery
Date received: 1987-05-13
Decision date: 1987-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

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Adverse events under product code LRO

product code LRO

Injury: 975
Malfunction: 14,038
Other: 2
Total: 15,015

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.