Cleared Traditional

K253910 - Stitch - Suture Wires and Tapes

K253910 is an FDA 510(k) clearance for Stitch - Suture Wires and Tapes, manufactured by GM Dos Reis Industria e Comercio Ltda.. The device is a Class 2 General & Plastic Surgery device with product code GAT cleared through the Traditional 510(k) pathway after a 257-day FDA review.

K253910 · GM Dos Reis Industria e Comercio Ltda. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
257d
Days
Class 2
Risk

K253910 is an FDA 510(k) clearance for the Stitch - Suture Wires and Tapes. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by GM Dos Reis Industria e Comercio Ltda. (Campinas, BR). The FDA issued a Cleared decision on August 22, 2026 after a review of 257 days - an extended review cycle.

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 GM Dos Reis Industria e Comercio Ltda. devices

FDA 510(k) Submission Details - K253910

510(k) Number K253910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2025
Decision Date August 22, 2026
Days to Decision 257 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
142d slower than avg
Panel avg: 115d · This submission: 257d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAT Device Classification - Class 2, Special Controls

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 121
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K253910.
EasyWhip Family
K261021 · Winter Innovations, Inc. · Jul 2026
Polyethylene
K260775 · Teleflex Medical, LLC · May 2026
HyperSuture All Green Extension Line
K254275 · Threadstone, LLC · Mar 2026
Meniscus Versaflex
K254188 · GM Dos Reis Industria e Comercio Ltda. · Feb 2026
Pre-Sutured Tendon
K253145 · Rti Surgical, Inc. · Oct 2025
ProZip Knotless Implant
K253024 · Riverpoint Medical · Oct 2025