Cleared Special

PTFE SURGICAL SUTURE

K180630 · Omnia Spa · General & Plastic Surgery

Apr 2018

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K180630 is an FDA 510(k) clearance for the PTFE SURGICAL SUTURE, a Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene (Class II — Special Controls, product code NBY), submitted by Omnia Spa (Fidenza, IT). The FDA issued a Cleared decision on April 6, 2018, 28 days after receiving the submission on March 9, 2018. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5035.

Submission Details

510(k) Number	K180630 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 09, 2018
Decision Date	April 06, 2018
Days to Decision	28 days
Submission Type	Special
Review Panel	General & Plastic Surgery (SU)
Summary	Statement

Device Classification

Product Code	NBY — Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.5035