Cleared Traditional

K190777 - DemeTECH DemeFORCE Nonabsorbable Surgic...

K190777 is the FDA 510(k) clearance for DemeTECH DemeFORCE Nonabsorbable Surgic... by Demetech Corporation. It is a Class 2 General & Plastic Surgery device (product code GAT) cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K190777 · Demetech Corporation · General & Plastic Surgery device
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Jul 2019
Decision
127d
Days
Class 2
Risk

K190777 is an FDA 510(k) clearance for the DemeTECH DemeFORCE Nonabsorbable Surgical Suture. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Demetech Corporation (Miami Lakes, US). The FDA issued a Cleared decision on July 31, 2019 after a review of 127 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5000 - 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 Demetech Corporation devices

Submission Details

510(k) Number K190777 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2019
Decision Date July 31, 2019
Days to Decision 127 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
12d slower than avg
Panel avg: 115d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5000
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 - GAT Suture, Nonabsorbable, Synthetic, Polyethylene

All 94
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K190777.
Arthrex SutureTape
K193575 · Arthrex, Inc. · Jul 2020
Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch
K192490 · Teleflex Medical · Mar 2020
High Strength Suture
K192637 · Yunyi (Beijing) Medical Device Co., Ltd. · Mar 2020
Force Fiber Suture
K191268 · Teleflex Medical Incorporated · Jun 2019
HS Fiber
K190817 · Riverpoint Medical · May 2019
MTF Pre-Sutured Tendon
K181633 · Musculoskeletal Transplant Foundation · Mar 2019