Medela Low Dose Enteral Syringe— 510(k) K161811

Substantially Equivalent

Medela, Inc.

FDA 510(k) clearance K161811 for Medela Low Dose Enteral Syringe, Substantially Equivalent on 2017-02-15. Applicant: Medela, Inc..

Clearance details

Applicant: Medela, Inc.
Product code: Code PNR
Advisory panel: Gastroenterology, Urology
Date received: 2016-07-01
Decision date: 2017-02-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, 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.