PREFILLED WATER FOR IRRIGATION USP— 510(k) K880316

Substantially Equivalent

Automatic Liquid Packaging, Inc.

FDA 510(k) clearance K880316 for PREFILLED WATER FOR IRRIGATION USP, Substantially Equivalent on 1988-02-29. Applicant: Automatic Liquid Packaging, Inc..

Clearance details

Applicant: Automatic Liquid Packaging, Inc.
Product code: Code BTO
Advisory panel: Anesthesiology
Date received: 1988-01-26
Decision date: 1988-02-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woodstock, IL, US

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Adverse events under product code BTO

product code BTO

Death: 14
Injury: 328
Malfunction: 1,851
Total: 2,193

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.