Cleared Special

PACKAGING TRAY AND COMPONENTS (K040707) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K040707 · Vygon Us, LLC · General Hospital
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Apr 2004
Decision
29d
Days
Class 2
Risk

K040707 is an FDA 510(k) clearance for the PACKAGING TRAY AND COMPONENTS. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Vygon Us, LLC (Norristown, US). The FDA issued a Cleared decision on April 16, 2004 after a review of 29 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - the FDA general hospital 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.

View all Vygon Us, LLC devices

Submission Details

510(k) Number K040707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2004
Decision Date April 16, 2004
Days to Decision 29 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 129d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FRG Wrap, Sterilization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6850
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 Hospital devices follow this clearance model.

Regulatory Peers - FRG Wrap, Sterilization

All 321
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K243179 · Yichang Xinxin Paper Products Co., Ltd. · Jun 2025