4 SURE URINARY DRAIN BAG— 510(k) K896727

Substantially Equivalent

The Boston & Pacific Co., Inc.

FDA 510(k) clearance K896727 for 4 SURE URINARY DRAIN BAG, Substantially Equivalent on 1990-02-20. Applicant: The Boston & Pacific Co., Inc..

Clearance details

Applicant: The Boston & Pacific Co., Inc.
Product code: Code KNX
Advisory panel: Gastroenterology, Urology
Date received: 1989-11-29
Decision date: 1990-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hingham, MA, US

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Adverse events under product code KNX

product code KNX

Malfunction: 1,064
Total: 1,064

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.