DeviceClearance

Product code PNR— Gastroenterology, Urology

Oral/Enteral Syringe with ENFit connector

Classification name
Enteral Syringes With Enteral Specific Connectors
Device class
Class 2
Regulation
21 CFR 876.5980
Advisory panel
Gastroenterology, Urology
Total cleared
35
First cleared
Most recent

FDA classification definition

“Delivers nutrition, medication, or hydration orally or to a gastrointestinal tube or extension set using AAMI/CN3(PS):2014 compliant connectors.”

— U.S. Food and Drug Administration, device classification record for product code PNR under 21 CFR 876.5980, via openFDA

Market context for product code PNR

FDA has cleared 35 devices under product code PNR between 2015 and 2026, filed by 23 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PNR

Adverse events under product code PNR

product code PNR
Other
6
Total
6

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 →

Recent clearances under product code PNR

Data sourced from openFDA. This site is unofficial and independent of the FDA.