DeviceClearance

Protégé EverFlex Self-expanding Peripheral Stent System— 510(k) K262913

Substantially Equivalent

Medtronic, Inc.

FDA 510(k) clearance K262913 for Protégé EverFlex Self-expanding Peripheral Stent System, Substantially Equivalent on 2026-09-17. Applicant: Medtronic, Inc.. Device class: 2.

Summary

Protégé EverFlex Self-expanding Peripheral Stent System is from Medtronic, Inc., filed under product code FGE (Stents, Drains And Dilators For The Biliary Ducts). The record has nothing on the system beyond its name and code.

Class II, 21 CFR 876.5010. Gastroenterology, Urology is both the classification panel and the review panel, and it came in as a Special 510(k). The decision was Substantially Equivalent.

Medtronic filed from Plymouth, Minnesota. The decision came 29 calendar days after receipt (August 19 to September 17, 2026).

Clearance details

Applicant
Medtronic, Inc.
Product code
Product code FGE
Device class
Class 2
Regulation
21 CFR 876.5010
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Plymouth, MN, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code FGE

product code FGE
Death
52
Injury
2,347
Malfunction
9,798
Other
1
Total
12,198

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.