Cleared Traditional

K863505 - URESIL CLOSED DRAINAGE RESERVOIR

K863505 is an FDA 510(k) clearance for URESIL CLOSED DRAINAGE RESERVOIR, manufactured by Uresil Corp.. The device is a Class 1 General & Plastic Surgery device with product code GCY cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K863505 · Uresil Corp. · General & Plastic Surgery device
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Sep 1986
Decision
9d
Days
Class 1
Risk

K863505 is an FDA 510(k) clearance for the URESIL CLOSED DRAINAGE RESERVOIR. Classified as Apparatus, Suction, Single Patient Use, Portable, Nonpowered (product code GCY), Class I - General Controls.

Submitted by Uresil Corp. (Skokie, US). The FDA issued a Cleared decision on September 18, 1986 after a review of 9 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 Uresil Corp. devices

FDA 510(k) Submission Details - K863505

510(k) Number K863505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1986
Decision Date September 18, 1986
Days to Decision 9 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
106d faster than avg
Panel avg: 115d · This submission: 9d
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 K863505.
HEYER-SCHULTE(R) 100CC & 400CC EXUDATE DISP. BAGS
K880650 · Baxter Healthcare Corp · Feb 1988
MAXIVAC(TM) CLOSED WOUND SUCTION DRAINAGE SYSTEM
K873332 · American V. Mueller · Sep 1987
URESIL 150CC BELLOWS RESERVOIR
K863562 · Uresil Corp. · Sep 1986
NEW USE FOR ACUVAC SUCTION RESERVOIR 400CC
K863201 · Allergan, Inc. · Aug 1986
BARD PARKER 150CC BELLOWS RESERVOIR
K854424 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1985
ECONOMY 400 CWS WITH PVC DRAINS
K851084 · C.R. Bard, Inc. · Jun 1985