FDA product code FHM: Apparatus, Suturing, Stomach And Intestinal

FHM is the FDA product code for apparatus, suturing, stomach and intestinal. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 2 510(k) submissions under FHM. The average 510(k) review took 24 days (median 24).

Classification

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

Top FHM applicants

Most recent FHM clearances

Recalls for FHM devices

openFDA lists no recalls for product code FHM.

Frequently asked questions

What is FDA product code FHM?

FHM is the FDA product code for apparatus, suturing, stomach and intestinal. 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 FHM?

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

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

Across 2 cleared submissions the average was 24 days from receipt to decision (median 24).

Which companies have the most FHM clearances?

United States Surgical, A Division of Tyco Healthc (2).

Next steps

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

All General and Plastic Surgery product codes · FDA product code lookup · 510(k) database search · 510(k) review times