FDA product code FHC: Adaptor To The Cord, For Transurethral Surgical Instrument

FHC is the FDA product code for adaptor to the cord, for transurethral surgical instrument. It is a Class II device, regulated under 21 CFR 876.4300 and reviewed by the Gastroenterology and Urology panel. Devices under FHC reach the market by 510(k); FDA lists no cleared 510(k)s for it.

Classification

FieldValue
Device nameAdaptor To The Cord, For Transurethral Surgical Instrument
Device classClass II
Regulation21 CFR 876.4300
Review panelGU — Gastroenterology and Urology
Medical specialtyGastroenterology, Urology
Premarket route510(k)

Recalls for FHC devices

openFDA lists no recalls for product code FHC.

Frequently asked questions

What is FDA product code FHC?

FHC is the FDA product code for adaptor to the cord, for transurethral surgical instrument. It is a Class II device, regulated under 21 CFR 876.4300 and reviewed by the Gastroenterology and Urology panel.

What device class is FHC?

Class II, regulation 21 CFR 876.4300. Typical premarket route: 510(k).

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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