Cleared Traditional

K800014 - DOW CORNING/W RIGHT WOUND DRAINAGE SYS

K800014 is an FDA 510(k) clearance for DOW CORNING/W RIGHT WOUND DRAINAGE SYS, manufactured by Dow Corning Corp. Healthcare Industries Materials. The device is a Class 1 General & Plastic Surgery device with product code GCY cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K800014 · Dow Corning Corp. Healthcare Industries Materials · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1980
Decision
13d
Days
Class 1
Risk

K800014 is an FDA 510(k) clearance for the DOW CORNING/W RIGHT WOUND DRAINAGE SYS. Classified as Apparatus, Suction, Single Patient Use, Portable, Nonpowered (product code GCY), Class I - General Controls.

Submitted by Dow Corning Corp. Healthcare Industries Materials (Mchenry, US). The FDA issued a Cleared decision on January 17, 1980 after a review of 13 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 Dow Corning Corp. Healthcare Industries Materials devices

FDA 510(k) Submission Details - K800014

510(k) Number K800014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1980
Decision Date January 17, 1980
Days to Decision 13 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 115d · This submission: 13d
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 49
Devices cleared under the same product code (GCY) and FDA review panel - the closest regulatory comparables to K800014.
ARGYLE VAC-U-CARE 100CC SUCT. RESERVOIR
K801372 · Sherwood Medical Co. · Jun 1980
SURGITEK FOERSTER FACE LIFT DRAIN
K800331 · Medical Engineering Corp. · Mar 1980
DAVOL/ABAMSON SILICONE SUMP DRAIN
K800081 · Davol, Inc. · Jan 1980
CLOSED WOUND VACUUM DRAINAGE SYSTEM
K790654 · 3M Company · Apr 1979
ROUND SILICONE DRAIN
K782028 · Davol, Inc. · Dec 1978
FLAT SILICONE DRAIN
K782026 · Davol, Inc. · Dec 1978