Cleared Traditional

Barbed PDO Suture (K252171) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K252171 · Sutura Medical Technology, Inc. · General & Plastic Surgery device
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Jun 2026
Decision
337d
Days
Class 2
Risk

K252171 is an FDA 510(k) clearance for the Barbed PDO Suture. Classified as Suture, Surgical, Absorbable, Polydioxanone (product code NEW), Class II - Special Controls.

Submitted by Sutura Medical Technology, Inc. (Dedham, US). The FDA issued a Cleared decision on June 12, 2026 after a review of 337 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4840 - 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. Elevated predicate reliance profile. 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 Sutura Medical Technology, Inc. devices

Submission Details

510(k) Number K252171 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2025
Decision Date June 12, 2026
Days to Decision 337 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
222d slower than avg
Panel avg: 115d · This submission: 337d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NEW Suture, Surgical, Absorbable, Polydioxanone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4840
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 - NEW Suture, Surgical, Absorbable, Polydioxanone

All 27
Devices cleared under the same product code (NEW) and FDA review panel - the closest regulatory comparables to K252171.
STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices
K252047 · Ethicon, Inc. · May 2026
PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture
K243897 · Ethicon, Inc. · Nov 2025
Miracu™ Polydioxanone (PDO) Suture and Needle (MONO)
K251414 · Feeltech Co., Ltd. · Oct 2025
V-soft Line™ Barbed Surgical Suture (Various)
K250107 · Feeltech Co., Ltd. · Oct 2025
PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture
K252644 · M/s. Meril Endo Surgery Private Limited. · Sep 2025
Suture-TOOL System
K250977 · Suturion AB · Apr 2025