Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, Exempt
The Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile (Exempt) is a general/plastic surgery device consisting of sterile stainless steel suture material in both monofilament and multifilament configurations, used to close wounds and approximate tissue during surgical procedures where long-term or permanent closure is required. Product code PTX is the Class II exempt counterpart of GAQ, exempted from the 510(k) requirement under the 21st Century Cures Act, subject to the limitations in 21 CFR 878.9. Under regulation 21 CFR 878.4495, it is a Class II device subject to general and special controls. It is flagged as an implant, reflecting its use as a permanent or long-term tissue approximation device.
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Basic Information
- Product Code
- PTX
- Device Class
- FDA class 2
- Regulation Number
- 878.4495
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.