DRAINAGE BAG, IMPROVED, FLAT— 510(k) K770490

Substantially Equivalent

Pharmaseal Div., Baxter Healthcare Corp.

FDA 510(k) clearance K770490 for DRAINAGE BAG, IMPROVED, FLAT, Substantially Equivalent on 1977-03-21. Applicant: Pharmaseal Div., Baxter Healthcare Corp..

Clearance details

Applicant: Pharmaseal Div., Baxter Healthcare Corp.
Product code: Code KNX
Advisory panel: Gastroenterology, Urology
Date received: 1977-03-14
Decision date: 1977-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.