FDA product code FTN: Plastic Surgery And Accessories Kit

FTN is the FDA product code for plastic surgery and accessories kit. It is a Class I device, regulated under 21 CFR 878.3925 and reviewed by the General and Plastic Surgery panel. Devices under FTN reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 63 recalls for FTN devices, 40 initiated in the last five years.

Definition

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Classification

Recalls for FTN devices

63 product recalls in 40 recall events; 40 initiated in the last five years and 40 still open. Most recent: 2026-07-10.

Frequently asked questions

What is FDA product code FTN?

FTN is the FDA product code for plastic surgery and accessories kit. It is a Class I device, regulated under 21 CFR 878.3925 and reviewed by the General and Plastic Surgery panel.

What device class is FTN?

Class I, regulation 21 CFR 878.3925. Typical premarket route: 510(k) exempt.

Have FTN devices been recalled?

Yes: 63 product recalls across 40 recall events; the most recent began 2026-07-10.

Next steps

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