Cleared Traditional

TLS TM SURGICAL DRAINAGE SYSTEM (K800581) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K800581 · Glasrock Products, Inc. · General & Plastic Surgery device
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Apr 1980
Decision
21d
Days
Class 1
Risk

K800581 is an FDA 510(k) clearance for the TLS TM SURGICAL DRAINAGE SYSTEM. Classified as Apparatus, Suction, Single Patient Use, Portable, Nonpowered (product code GCY), Class I - General Controls.

Submitted by Glasrock Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 4, 1980 after a review of 21 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 Glasrock Products, Inc. devices

Submission Details

510(k) Number K800581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1980
Decision Date April 04, 1980
Days to Decision 21 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
94d faster than avg
Panel avg: 115d · This submission: 21d
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

All 18
Devices cleared under the same product code (GCY) and FDA review panel - the closest regulatory comparables to K800581.
FRAZIER-FERGUSON SUCTION TUBES (DISP.)
K801612 · Edward Weck, Inc. · Aug 1980
ARGYLE VAC-U-CARE FLAT SILICONE WOUND T.
K801371 · Sherwood Medical Co. · Jun 1980
ARGYLE VAC-U-CARE 100CC SUCT. RESERVOIR
K801372 · Sherwood Medical Co. · Jun 1980
CLOSED WOUND VACUUM DRAINAGE SYSTEM
K790654 · 3M Company · Apr 1979
PORTABLE CLOSED WOUND SUCTION EVACUATOR
K780848 · Biomet, Inc. · Aug 1978
ARGYLE SUCTION CONTROL KIT
K760601 · Sherwood Medical Co. · Nov 1976