IMPROVED BAKER TWIN-CUFF SUMP TUBE— 510(k) K901683

Substantially Equivalent

Bissell Medical Products, Inc.

FDA 510(k) clearance K901683 for IMPROVED BAKER TWIN-CUFF SUMP TUBE, Substantially Equivalent on 1990-06-27. Applicant: Bissell Medical Products, Inc..

Clearance details

Applicant: Bissell Medical Products, Inc.
Product code: Code KNT
Advisory panel: Gastroenterology, Urology
Date received: 1990-04-10
Decision date: 1990-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Naperville, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KNT

product code KNT

Death: 192
Injury: 6,034
Malfunction: 4,049
Other: 1
Total: 10,276

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.