Cleared Traditional

K840913 - PROVAC WOUND DRAINAGE & HEALING SYS

K840913 is an FDA 510(k) clearance for PROVAC WOUND DRAINAGE & HEALING SYS, manufactured by Meyer Medical U.S.A., Inc.. The device is a Class 1 General & Plastic Surgery device with product code GCY cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K840913 · Meyer Medical U.S.A., Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1984
Decision
55d
Days
Class 1
Risk

K840913 is an FDA 510(k) clearance for the PROVAC WOUND DRAINAGE & HEALING SYS. Classified as Apparatus, Suction, Single Patient Use, Portable, Nonpowered (product code GCY), Class I - General Controls.

Submitted by Meyer Medical U.S.A., Inc.. The FDA issued a Cleared decision on April 24, 1984 after a review of 55 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4680 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Meyer Medical U.S.A., Inc. devices

FDA 510(k) Submission Details - K840913

510(k) Number K840913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 29, 1984
Decision Date April 24, 1984
Days to Decision 55 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 115d · This submission: 55d
Pathway characteristics
Predicate-based equivalence.

GCY Device Classification - Class 1, General Controls

Product Code GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4680
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 - GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered

All 52
Devices cleared under the same product code (GCY) and FDA review panel - the closest regulatory comparables to K840913.
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