Cleared Traditional

HYDROCOAT MESH (K090271) - FDA 510(k) Clearance

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

K090271 · Promethean Surgical Devices, Inc. · General & Plastic Surgery device
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Jan 2010
Decision
344d
Days
Class 2
Risk

K090271 is an FDA 510(k) clearance for the HYDROCOAT MESH. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Promethean Surgical Devices, Inc. (East Harford, US). The FDA issued a Cleared decision on January 14, 2010 after a review of 344 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 878.3300 - 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. 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 Promethean Surgical Devices, Inc. devices

Submission Details

510(k) Number K090271 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2009
Decision Date January 14, 2010
Days to Decision 344 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
229d slower than avg
Panel avg: 115d · This submission: 344d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FTL Mesh, Surgical, Polymeric
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 - FTL Mesh, Surgical, Polymeric

All 335
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