Cleared Traditional

K880895 - URESIL WOUND DRAIN TROCAR

K880895 is an FDA 510(k) clearance for URESIL WOUND DRAIN TROCAR, manufactured by Uresil Corp.. The device is a Class 1 General & Plastic Surgery device with product code GBS cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K880895 · Uresil Corp. · General & Plastic Surgery device
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Mar 1988
Decision
12d
Days
Class 1
Risk

K880895 is an FDA 510(k) clearance for the URESIL WOUND DRAIN TROCAR. Classified as Catheter, Ventricular, General & Plastic Surgery (product code GBS), Class I - General Controls.

Submitted by Uresil Corp. (Skokie, US). The FDA issued a Cleared decision on March 14, 1988 after a review of 12 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4200 - 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 - K880895

510(k) Number K880895 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1988
Decision Date March 14, 1988
Days to Decision 12 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
103d faster than avg
Panel avg: 115d · This submission: 12d
Pathway characteristics
Predicate-based equivalence.

GBS Device Classification - Class 1, General Controls

Product Code GBS Catheter, Ventricular, General & Plastic Surgery
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4200
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 - GBS Catheter, Ventricular, General & Plastic Surgery

All 17
Devices cleared under the same product code (GBS) and FDA review panel - the closest regulatory comparables to K880895.
ATRIUMS PDR THORACIC CATHETER
K912645 · Atrium Medical Corp. · Sep 1991
INTRODUCTION/DRAINAGE CATHETER & ACCESS
K881873 · Sheridan Catheter Corp. · May 1988
CLOSED CHEST DRAINAGE SET W/SUTURES
K873377 · Gish Biomedical, Inc. · Oct 1987
URESIL STD FLAT/ROUND & FLAT/ROUND SPLIT. SILI/DRA
K863560 · Uresil Corp. · Sep 1986
THORACIC CATHETER (CHEST DRAINAGE TUBE)
K863142 · Sheridan Catheter Corp. · Aug 1986
AXIOM TROCAR THORACIC CATHETER
K863247 · Axiom Medical, Inc. · Aug 1986