Cleared Special

K171357 - SurgiMend PRS Meshed, Revize-X

K171357 is an FDA 510(k) clearance for SurgiMend PRS Meshed, manufactured by Integra Lifesciences Corporation (Owner of Tei Biosciences). The device is a Class 2 General & Plastic Surgery device with product code OXH cleared through the Special 510(k) pathway after a 29-day FDA review.

K171357 · Integra Lifesciences Corporation (Owner of Tei Biosciences) · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2017
Decision
29d
Days
Class 2
Risk

K171357 is an FDA 510(k) clearance for the SurgiMend PRS Meshed, Revize-X. Classified as Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery (product code OXH), Class II - Special Controls.

Submitted by Integra Lifesciences Corporation (Owner of Tei Biosciences) (Boston, US). The FDA issued a Cleared decision on June 7, 2017 after a review of 29 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.

FDA 510(k) Submission Details - K171357

510(k) Number K171357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2017
Decision Date June 07, 2017
Days to Decision 29 days
Submission Type Special
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
86d faster than avg
Panel avg: 115d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

OXH Device Classification - Class 2, Special Controls

Product Code OXH Mesh, Surgical, Collagen, 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 Consultant

Integra LifeSciences Corporation
Kavita Amin

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

K171357 · SurgiMend PRS Meshed, Revize-X
Download PDF FDA Summary Integra Lifesciences …