Cleared Special

K172545 - SERI Contour (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
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.

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
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 132d · 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.