Cleared Special

SERI Contour (K172545) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K172545 · Sofregen Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2017
Decision
30d
Days
Class 2
Risk

K172545 is an FDA 510(k) clearance for the SERI Contour. Classified as Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery (product code OXF), Class II - Special Controls.

Submitted by Sofregen Medical, Inc. (Medford, US). The FDA issued a Cleared decision on September 22, 2017 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 878.3300 - 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 Sofregen Medical, Inc. devices

Submission Details

510(k) Number K172545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2017
Decision Date September 22, 2017
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
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 OXF Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
Definition For Reinforcement Of Soft Tissue Where Weakness Exists In Plastic And Reconstructive Surgery.
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 - OXF Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery

All 7
Devices cleared under the same product code (OXF) and FDA review panel - the closest regulatory comparables to K172545.
Restrata Soft Tissue Reinforcement (STR)
K251224 · Acera Surgical, Inc. · Jun 2025
3DMatrix DynaFlex (DynaFlex)
K243302 · Printbio, Inc. · May 2025
3DMatrix Surgical Mesh
K232602 · Printbio, Inc. · May 2024
GORE® ENFORM Biomaterial
K222919 · W. L. Gore and Associates, Inc. · Dec 2022
GORE ENFORM Biomaterial
K173333 · W.L. Gore & Associates, Inc. · Apr 2018
GORE BIO-A Tissue Reinforcement
K163217 · W.L. Gore & Associates, Inc. · Feb 2017