HOLLISTER(R) BEDSIDE DRAINAGE COLLECTION SYST 9878— 510(k) K926570

Substantially Equivalent

Hollister, Inc.

FDA 510(k) clearance K926570 for HOLLISTER(R) BEDSIDE DRAINAGE COLLECTION SYST 9878, Substantially Equivalent on 1993-05-21. Applicant: Hollister, Inc..

Clearance details

Applicant
Hollister, Inc.
Product code
Code KNX
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Libertyville, IL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code KNX

product code KNX
Malfunction
1,064
Total
1,064

Source: openFDA MAUDE database, through . 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.