Cleared Traditional

K950754 - MACRO SUCTION TUBE MODEL NO 10061

K950754 is the FDA 510(k) clearance for MACRO SUCTION TUBE MODEL NO 10061 by Dlp, Inc.. It is a Class 1 General & Plastic Surgery device (product code GCY) cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K950754 · Dlp, Inc. · General & Plastic Surgery device
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Apr 1995
Decision
67d
Days
Class 1
Risk

K950754 is an FDA 510(k) clearance for the MACRO SUCTION TUBE MODEL NO 10061. Classified as Apparatus, Suction, Single Patient Use, Portable, Nonpowered (product code GCY), Class I - General Controls.

Submitted by Dlp, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on April 25, 1995 after a review of 67 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 Dlp, Inc. devices

Submission Details

510(k) Number K950754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1995
Decision Date April 25, 1995
Days to Decision 67 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 115d · This submission: 67d
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 43
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