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FDA 510(k)

Percutaneous Endoscopic Gastrostomy (PEG) Kit

K-Number: K254170 · 2026-03-20

ApplicantDegania Silicone , Ltd.
Decision Date2026-03-20
Product CodePIF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Percutaneous Endoscopic Gastrostomy (PEG) Kit is a medical device manufactured by Degania Silicone , Ltd.. It received FDA 510(k) clearance on 2026-03-20 under approval number K254170. The device is classified under product code PIF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Percutaneous Endoscopic Gastrostomy (PEG) Kit?

Percutaneous Endoscopic Gastrostomy (PEG) Kit is a medical device that received FDA 510(k) clearance on 2026-03-20. It is manufactured by Degania Silicone , Ltd.. The 510(k) number is K254170.

When was Percutaneous Endoscopic Gastrostomy (PEG) Kit approved by the FDA?

Percutaneous Endoscopic Gastrostomy (PEG) Kit received FDA 510(k) clearance on 2026-03-20, under approval number K254170.

What company makes Percutaneous Endoscopic Gastrostomy (PEG) Kit?

Percutaneous Endoscopic Gastrostomy (PEG) Kit is manufactured by Degania Silicone , Ltd..

What is the FDA product code for Percutaneous Endoscopic Gastrostomy (PEG) Kit?

The FDA product code for Percutaneous Endoscopic Gastrostomy (PEG) Kit is PIF.

Related Clinical Trials

NCT07595835 CT-guided Percutaneous Radionuclide Therapy With 32P Microparticles in Patients With Non-progressive Locally Advanced Pancreatic Cancer RECRUITING NCT04362592 In-Utero Endoscopic Correction of Spina Bifida ACTIVE_NOT_RECRUITING

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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