Cleared Traditional

K231277 - TissueStat

K231277 is an FDA 510(k) clearance for TissueStat, manufactured by Durastat, LLC. The device is a Class 2 General & Plastic Surgery device with product code NBY cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K231277 · Durastat, LLC · General & Plastic Surgery device
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Nov 2023
Decision
190d
Days
Class 2
Risk

K231277 is an FDA 510(k) clearance for the TissueStat. Classified as Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene (product code NBY), Class II - Special Controls.

Submitted by Durastat, LLC (Austin, US). The FDA issued a Cleared decision on November 9, 2023 after a review of 190 days - an extended review 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Durastat, LLC devices

FDA 510(k) Submission Details - K231277

510(k) Number K231277 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2023
Decision Date November 09, 2023
Days to Decision 190 days
Submission Type Traditional
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
75d slower than avg
Panel avg: 115d · This submission: 190d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NBY Device Classification - Class 2, Special Controls

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 8
Devices cleared under the same product code (NBY) and FDA review panel - the closest regulatory comparables to K231277.
GOLNIT Non-aborbable PTFE Surgical Suture
K192088 · Antarma, LLC Dba Golnit Sutures · Sep 2019
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