Medline ENfit OTC Feeding Syringe— 510(k) K202285

Substantially Equivalent

Medline Industries, Inc.

FDA 510(k) clearance K202285 for Medline ENfit OTC Feeding Syringe, Substantially Equivalent on 2020-10-09. Applicant: Medline Industries, Inc..

Clearance details

Applicant: Medline Industries, Inc.
Product code: Code PNR
Advisory panel: Gastroenterology, Urology
Date received: 2020-08-12
Decision date: 2020-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northfiled, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code PNR

product code PNR

Other: 6
Total: 6

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.