FDA product code FZG: Apparatus, Air Handling, Bench

FZG is the FDA product code for apparatus, air handling, bench. It is a Class II device, regulated under 21 CFR 878.5070 and reviewed by the General and Plastic Surgery panel. FDA has cleared 1 510(k) submission under FZG. The average 510(k) review took 86 days (median 86).

Classification

Compare with all 510(k) review times · Search every FZG clearance

Top FZG applicants

Most recent FZG clearances

Recalls for FZG devices

openFDA lists no recalls for product code FZG.

Frequently asked questions

What is FDA product code FZG?

FZG is the FDA product code for apparatus, air handling, bench. It is a Class II device, regulated under 21 CFR 878.5070 and reviewed by the General and Plastic Surgery panel.

What device class is FZG?

Class II, regulation 21 CFR 878.5070. Typical premarket route: 510(k) exempt.

How long does a 510(k) take for product code FZG?

Across 1 cleared submissions the average was 86 days from receipt to decision (median 86).

Which companies have the most FZG clearances?

V. Mueller O.V. Baxter Healthcare Corp. (1).

Next steps

• Run an FDA pathway report with predicate devices for product code FZG
• Run a recall and safety report across every FZG manufacturer
• Watch product code FZG for new clearances and recalls

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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