DeviceClearance

Product code PIF— Gastroenterology, Urology

EnteraLoc Flow

Classification name
Gastrointestinal Tubes With Enteral Specific Connectors
Device class
Class 2
Regulation
21 CFR 876.5980
Advisory panel
Gastroenterology, Urology
Total cleared
52
First cleared
Most recent

FDA classification definition

“To facilitate enteral specific connections.”

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

Market context for product code PIF

FDA has cleared 52 devices under product code PIF between 2014 and 2026, filed by 36 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 PIF

Adverse events under product code PIF

product code PIF
Death
13
Injury
122
Other
1
Total
136

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 PIF

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