NBY

Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene

Product code: NBY
Device name: Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
Device class: Class 2
21 CFR: 21 CFR 878.5035
Medical specialty: General, Plastic Surgery
Marketing pathway: 510(K)
Flag: Implant
510(k) clearances (last 3 years): 17

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2023-11-09.

Number	Decision date	Applicant	Device name	Summary
K231277	2023-11-09	Durastat, LLC	TissueStat	PDF

1 summaries are archived here for direct download.

Official FDA classification page: NBY

Classification and pathway per current FDA publications. Data from openFDA (CC0).