FDA product code FZY: Hammer, Surgical

FZY is the FDA product code for hammer, surgical. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 1 510(k) submission under FZY. The average 510(k) review took 27 days (median 27). FDA has posted 2 recalls for FZY devices.

Classification

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

Top FZY applicants

Most recent FZY clearances

Recalls for FZY devices

2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-04-25.

Frequently asked questions

What is FDA product code FZY?

FZY is the FDA product code for hammer, surgical. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel.

What device class is FZY?

Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 27 days from receipt to decision (median 27).

Which companies have the most FZY clearances?

Midshore Welding Corp. (1).

Have FZY devices been recalled?

Yes: 2 product recalls across 2 recall events; the most recent began 2013-04-25.

Next steps

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