Jostent Selfx, Models 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808; 015SX6810

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K030053 ↗

FDA Product Code

FGE

Models / Variants

Jostent Selfx, Models 015SX4406

015SX4408

015SX4410

015SX680

015SX6808

015SX6810

Device Class

Class II

Regulation

21 CFR Part 876.5010

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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See all devices from Jomed AG →