Cleared Traditional

K072560 - ENVELA (HYDROHESIVE OCCLUSIVE DRESSING)

K072560 is an FDA 510(k) clearance for ENVELA (HYDROHESIVE OCCLUSIVE DRESSING), manufactured by Teikoku Pharma USA, Inc.. The device is a Class 1 General & Plastic Surgery device with product code NAD cleared through the Traditional 510(k) pathway after a 280-day FDA review.

K072560 · Teikoku Pharma USA, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2008
Decision
280d
Days
Class 1
Risk

K072560 is an FDA 510(k) clearance for the ENVELA (HYDROHESIVE OCCLUSIVE DRESSING). Classified as Dressing, Wound, Occlusive (product code NAD), Class I - General Controls.

Submitted by Teikoku Pharma USA, Inc. (San Jose, US). The FDA issued a Cleared decision on June 17, 2008 after a review of 280 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4020 - 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.

FDA 510(k) Submission Details - K072560

510(k) Number K072560 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2007
Decision Date June 17, 2008
Days to Decision 280 days
Submission Type Traditional
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
165d slower than avg
Panel avg: 115d · This submission: 280d
Pathway characteristics
Predicate-based equivalence.

NAD Device Classification - Class 1, General Controls

Product Code NAD Dressing, Wound, Occlusive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4020
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - NAD Dressing, Wound, Occlusive

All 100
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K072560 · ENVELA (HYDROHESIVE OCCLUSIVE DRESSING)
Download PDF FDA Summary Teikoku Pharma USA, I…