Cleared Special

K192088 - GOLNIT Non-aborbable PTFE Surgical Suture

K192088 is the FDA 510(k) clearance for GOLNIT Non-aborbable PTFE Surgical Suture by Antarma, LLC Dba Golnit Sutures. It is a Class 2 General & Plastic Surgery device (product code NBY) cleared through the Special 510(k) pathway after a 30-day FDA review.

K192088 · Antarma, LLC Dba Golnit Sutures · General & Plastic Surgery device
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Sep 2019
Decision
30d
Days
Class 2
Risk

K192088 is an FDA 510(k) clearance for the GOLNIT Non-aborbable PTFE Surgical Suture. Classified as Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene (product code NBY), Class II - Special Controls.

Submitted by Antarma, LLC Dba Golnit Sutures (New York, US). The FDA issued a Cleared decision on September 4, 2019 after a review of 30 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5035 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Antarma, LLC Dba Golnit Sutures devices

Submission Details

510(k) Number K192088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2019
Decision Date September 04, 2019
Days to Decision 30 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 115d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NBY Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5035
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - NBY Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene

All 7
Devices cleared under the same product code (NBY) and FDA review panel - the closest regulatory comparables to K192088.
TissueStat
K231277 · Durastat, LLC · Nov 2023
Biotex
K180992 · Purgo Biologics, Inc. · Jul 2019
StitchKit
K191317 · Origami Surgical · Jul 2019
DemeTECH PTFE Nonabsorbable Surgical Suture
K181578 · Demetech Corporation · Oct 2018
PTFE SURGICAL SUTURE
K180630 · Omnia Spa · Apr 2018
C-PTFETM Surgical Suture
K173922 · Cp Medical, Inc. · Mar 2018