FDA product code FTT: Camera, Still, Surgical

FTT is the FDA product code for camera, still, surgical. It is a Class I device, regulated under 21 CFR 878.4160 and reviewed by the General and Plastic Surgery panel. FDA has cleared 1 510(k) submission under FTT. The average 510(k) review took 25 days (median 25).

Classification

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

Top FTT applicants

Most recent FTT clearances

Recalls for FTT devices

openFDA lists no recalls for product code FTT.

Frequently asked questions

What is FDA product code FTT?

FTT is the FDA product code for camera, still, surgical. It is a Class I device, regulated under 21 CFR 878.4160 and reviewed by the General and Plastic Surgery panel.

What device class is FTT?

Class I, regulation 21 CFR 878.4160. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 25 days from receipt to decision (median 25).

Which companies have the most FTT clearances?

Diseases of the Skin Clinic, P.A. (1).

Next steps

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