FDA product code PTX: Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, Exempt

PTX is the FDA product code for suture, nonabsorbable, steel, monofilament and multifilament, sterile, exempt. It is a Class II device, regulated under 21 CFR 878.4495 and reviewed by the General and Plastic Surgery panel. Devices under PTX reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.

Definition

This product code is the class II exempt counterpart of GAQ, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 878.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.

Classification

Recalls for PTX devices

openFDA lists no recalls for product code PTX.

Frequently asked questions

What is FDA product code PTX?

PTX is the FDA product code for suture, nonabsorbable, steel, monofilament and multifilament, sterile, exempt. It is a Class II device, regulated under 21 CFR 878.4495 and reviewed by the General and Plastic Surgery panel.

What device class is PTX?

Class II, regulation 21 CFR 878.4495. Typical premarket route: 510(k) exempt.

Next steps

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