Cleared Traditional

TLS BULB DRAINAGE SYSTEM (K833586) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K833586 · Porex Medical · General & Plastic Surgery device
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Jan 1984
Decision
110d
Days
Class 1
Risk

K833586 is an FDA 510(k) clearance for the TLS BULB DRAINAGE SYSTEM. Classified as Apparatus, Suction, Single Patient Use, Portable, Nonpowered (product code GCY), Class I - General Controls.

Submitted by Porex Medical (Mchenry, US). The FDA issued a Cleared decision on January 30, 1984 after a review of 110 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Porex Medical devices

Submission Details

510(k) Number K833586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1983
Decision Date January 30, 1984
Days to Decision 110 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
5d faster than avg
Panel avg: 115d · This submission: 110d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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

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