Percutaneous Endoscopic Gastrostomy (PEG) Kit— 510(k) K254170
Substantially EquivalentDegania 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.
Summary
Degania Silicone's Percutaneous Endoscopic Gastrostomy (PEG) Kit is filed under PIF, gastrointestinal tubes with enteral specific connectors. The name is generic, and the record doesn't list kit contents or sizes.
Class II, 21 CFR 876.5980. Gastroenterology and Urology is both the classification panel and the review panel. It was a Traditional 510(k).
Degania Silicone filed from Degania Bet, Israel. The decision came 87 calendar days after receipt (December 23, 2025 to March 20, 2026).
Clearance details
- Applicant
- Degania Silicone , Ltd.
- Product code
- Product code PIF
- Device class
- Class 2
- Regulation
- 21 CFR 876.5980
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Degania Bet, IL
Recent devices under product code PIF
view allMore clearances from Degania Silicone , Ltd.
view allAdverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.