K982813

Substantially Equivalent

NATURALYTE, MODEL # 08-4004-1

Applicant: Kaybath, Inc.
Product code: KPO
Advisory panel: Gastroenterology, Urology
Date received: 1998-08-11
Decision date: 1998-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waipahu, HI, US

Adverse events under product code KPO

product code KPO

Death: 14
Malfunction: 775
Other: 20
Total: 809

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.