Cleared Traditional

K862584 - OSTEOTOMY DRAINAGE TUBE

K862584 is the FDA 510(k) clearance for OSTEOTOMY DRAINAGE TUBE by Treace Medical, Inc.. It is a Class 1 General & Plastic Surgery device (product code GBS) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K862584 · Treace Medical, Inc. · General & Plastic Surgery device
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Aug 1986
Decision
36d
Days
Class 1
Risk

K862584 is an FDA 510(k) clearance for the OSTEOTOMY DRAINAGE TUBE. Classified as Catheter, Ventricular, General & Plastic Surgery (product code GBS), Class I - General Controls.

Submitted by Treace Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on August 12, 1986 after a review of 36 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 Treace Medical, Inc. devices

Submission Details

510(k) Number K862584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1986
Decision Date August 12, 1986
Days to Decision 36 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
79d faster than avg
Panel avg: 115d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 K862584.
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
SILICONE SUMP DRAIN
K862767 · Sil-Med Corp. · Aug 1986
ROUND SUCTION DRAIN
K854418 · Sil-Med Corp. · Nov 1985
AXIOM ATRAUM TROCAR CATHETER
K852241 · Axiom Medical, Inc. · Jun 1985