GENERICA MEDICAL ENTERNAL DELIVERY; PUMP BAG SET, PUMP SPIKE SET, GRAVITY BAG SET— 510(k) K133077

Substantially Equivalent

Generica Medical International, Inc.

FDA 510(k) clearance K133077 for GENERICA MEDICAL ENTERNAL DELIVERY; PUMP BAG SET, PUMP SPIKE SET, GRAVITY BAG SET, Substantially Equivalent on 2014-07-28. Applicant: Generica Medical International, Inc..

Clearance details

Applicant: Generica Medical International, Inc.
Product code: Code KNT
Advisory panel: Gastroenterology, Urology
Date received: 2013-09-30
Decision date: 2014-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Verne, CA, 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.