FDA product code FJX: Ring, Crimp

FJX is the FDA product code for ring, crimp. It is a Class I device, regulated under 21 CFR 876.5540 and reviewed by the Gastroenterology and Urology panel. Devices under FJX reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.

Classification

FieldValue
Device nameRing, Crimp
Device classClass I
Regulation21 CFR 876.5540
Review panelGU — Gastroenterology and Urology
Medical specialtyGastroenterology, Urology
Premarket route510(k) exempt

Recalls for FJX devices

openFDA lists no recalls for product code FJX.

Frequently asked questions

What is FDA product code FJX?

FJX is the FDA product code for ring, crimp. It is a Class I device, regulated under 21 CFR 876.5540 and reviewed by the Gastroenterology and Urology panel.

What device class is FJX?

Class I, regulation 21 CFR 876.5540. Typical premarket route: 510(k) exempt.

Next steps

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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