Cleared Traditional

K033985 - PERIPATCH SLEEVE, MODELS G35, E35, G45, E45, G60, E60, 5C6, 5C8, 5C10

K033985 is an FDA 510(k) clearance for PERIPATCH SLEEVE, manufactured by Pm Devices, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTM cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K033985 · Pm Devices, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
164d
Days
Class 2
Risk

K033985 is an FDA 510(k) clearance for the PERIPATCH SLEEVE, MODELS G35, E35, G45, E45, G60, E60, 5C6, 5C8, 5C10. Classified as Mesh, Surgical (product code FTM), Class II - Special Controls.

Submitted by Pm Devices, Inc. (Richmond, Bc, CA). The FDA issued a Cleared decision on June 4, 2004 after a review of 164 days - an extended review 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. 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 Pm Devices, Inc. devices

FDA 510(k) Submission Details - K033985

510(k) Number K033985 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2003
Decision Date June 04, 2004
Days to Decision 164 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
49d slower than avg
Panel avg: 115d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FTM Device Classification - Class 2, Special Controls

Product Code FTM Mesh, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
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 - FTM Mesh, Surgical

All 94
Devices cleared under the same product code (FTM) and FDA review panel - the closest regulatory comparables to K033985.
THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX
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MEDPOR CRANIOFACIAL IMPLANTS WITH EMBEDDED TITANIUM MESH
K040364 · Porex Surgical, Inc. · Jun 2004
SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH
K040868 · Genzyme Corp. · Jun 2004
ACELL UBM SURGICAL MESH
K040621 · Acell, Inc. · Apr 2004
SIS PLASTIC SURGERY MATRIX
K034039 · Cook Biotech, Inc. · Feb 2004