DeviceClearance

Product code NBY— General, Plastic Surgery

PTFE SURGICAL SUTURE

Classification name
Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
Device class
Class 2
Regulation
21 CFR 878.5035
Advisory panel
General, Plastic Surgery
Total cleared
17
First cleared
Most recent

Market context for product code NBY

FDA has cleared 17 devices under product code NBY between 2000 and 2023, filed by 15 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code NBY

Recent clearances under product code NBY

Data sourced from openFDA. This site is unofficial and independent of the FDA.