Suture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride)
The Nonabsorbable Surgical Suture made of Poly(Vinylidene Fluoride) (PVDF) is a permanent synthetic suture used to approximate and close tissue during surgical procedures. PVDF sutures are known for their strength, flexibility, and biostability, making them suitable for cardiovascular, ophthalmic, and general surgical applications. Classified as FDA Class 2, it requires 510(k) premarket clearance under regulation 878.5010 (General and Plastic Surgery specialty). This device carries the implant flag as sutures are left in the body.
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Basic Information
- Product Code
- MXW
- Device Class
- FDA class 2
- Regulation Number
- 878.5010
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.