Percutaneous Endoscopic Gastrostomy (PEG) Kit— 510(k) K254170

Name: FDA 510(k) clearance K254170
Creator: U.S. Food and Drug Administration
Published: 2026-03-20

Substantially Equivalent

Degania Silicone , Ltd.

FDA 510(k) clearance K254170 for Percutaneous Endoscopic Gastrostomy (PEG) Kit, Substantially Equivalent on 2026-03-20. Applicant: Degania Silicone , Ltd.. Device class: 2.

Clearance details

Applicant: Degania Silicone , Ltd.
Product code: Code PIF
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 2025-12-23
Decision date: 2026-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Degania Bet, IL

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
K242917 — Enteral Drainage System, Enteral Medicine straw2025-06-18
K250481 — Extension Feeding Set with ENFit Connectors2025-04-18
K240052 — Disposable Enteral Feeding Sets2024-07-03

More clearances from Degania Silicone , Ltd.

view all

K233591 — Stylus2024-05-31
K152246 — Aquarius Stoma Measuring Device2016-06-21
K143378 — AQUARIUS Gastrostomy Replacement Tube2014-12-29
K141753 — AQUARIUS NASAL FEEDING TUBE2014-10-16
K141631 — AQUARIUS EXTENSION FEEDING SET2014-07-28

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.