PTX — Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, Exempt Class II
FDA product code PTX covers "Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, Exempt", a Class II medical device regulated under 21 CFR 878.4495. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants.
Classification Details
- Product Code
- PTX
- Device Class
- Class II
- Regulation Number
- 878.4495
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
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.