NBY · Class II · 21 CFR 878.5035

FDA Product Code NBY: Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene

Leading manufacturers include Origami Surgical, Antarma, LLC Dba Golnit Sutures and Durastat, LLC.

17
Total
17
Cleared
139d
Avg days
2000
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene Devices (Product Code NBY)

17 devices
1–17 of 17
Cleared Nov 09, 2023
TissueStat
K231277
Durastat, LLC
General & Plastic Surgery · 190d
Cleared Sep 04, 2019
GOLNIT Non-aborbable PTFE Surgical Suture
K192088
Antarma, LLC Dba Golnit Sutures
General & Plastic Surgery · 30d
Cleared Jul 16, 2019
Biotex
K180992
Purgo Biologics, Inc.
General & Plastic Surgery · 456d
Cleared Jul 12, 2019
StitchKit
K191317
Origami Surgical
General & Plastic Surgery · 58d
Cleared Oct 11, 2018
DemeTECH PTFE Nonabsorbable Surgical Suture
K181578
Demetech Corporation
General & Plastic Surgery · 118d
Cleared Apr 06, 2018
PTFE SURGICAL SUTURE
K180630
Omnia Spa
General & Plastic Surgery · 28d
Cleared Mar 26, 2018
C-PTFETM Surgical Suture
K173922
Cp Medical, Inc.
General & Plastic Surgery · 90d
Cleared Feb 08, 2018
Gazelle PTFE and Suture Delivery Device
K173335
Dura Tap, LLC
General & Plastic Surgery · 108d

About Product Code NBY - Regulatory Context

510(k) Submission Activity

17 total 510(k) submissions under product code NBY since 2000, with 17 receiving FDA clearance (average review time: 139 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.