FDA product code FFF: Cover, Biopsy Forceps

FFF is the FDA product code for cover, biopsy forceps. It is a Class I device, regulated under 21 CFR 876.1075 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under FFF. The average 510(k) review took 130 days (median 130). FDA has posted 5 recalls for FFF devices.

Classification

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

Top FFF applicants

Most recent FFF clearances

Recalls for FFF devices

5 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-12-18.

Frequently asked questions

What is FDA product code FFF?

FFF is the FDA product code for cover, biopsy forceps. It is a Class I device, regulated under 21 CFR 876.1075 and reviewed by the Gastroenterology and Urology panel.

What device class is FFF?

Class I, regulation 21 CFR 876.1075. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 130 days from receipt to decision (median 130).

Which companies have the most FFF clearances?

Amedic USA (1).

Have FFF devices been recalled?

Yes: 5 product recalls across 2 recall events; the most recent began 2018-12-18.

Next steps

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