EnteraLoc Flow— 510(k) K210971

Name: FDA 510(k) clearance K210971
Creator: U.S. Food and Drug Administration
Published: 2021-08-18

Substantially Equivalent

Vonco Products

FDA 510(k) clearance K210971 for EnteraLoc Flow, Substantially Equivalent on 2021-08-18. Applicant: Vonco Products. Device class: 2.

Clearance details

Applicant: Vonco Products
Product code: Code PIF
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 2021-03-31
Decision date: 2021-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Trevor, WI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PIF

view all

K260110 — danumed Extension Set for Gastrostomy Button2026-09-10
K253715 — Edi Catheter ENFit 6Fr/48 cm (6893166) +7 more2026-08-26
K254170 — Percutaneous Endoscopic Gastrostomy (PEG) Kit2026-03-20
K242917 — Enteral Drainage System, Enteral Medicine straw2025-06-18
K250481 — Extension Feeding Set with ENFit Connectors2025-04-18

More clearances from Vonco Products

view all

K223683 — EnteraLoc Flow2023-07-10

Adverse events under product code PIF

product code PIF

Death: 13
Injury: 122
Other: 1
Total: 136

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.