Cleared Traditional

K933170 - INMAN POOLE TIP SUCTION PROBE W/TUBING KIT

K933170 is an FDA 510(k) clearance for INMAN POOLE TIP SUCTION PROBE W/TUBING KIT, manufactured by Inman Medical Corp.. The device is a Class 1 General & Plastic Surgery device with product code GCY cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K933170 · Inman Medical Corp. · General & Plastic Surgery device
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Sep 1993
Decision
79d
Days
Class 1
Risk

K933170 is an FDA 510(k) clearance for the INMAN POOLE TIP SUCTION PROBE W/TUBING KIT. Classified as Apparatus, Suction, Single Patient Use, Portable, Nonpowered (product code GCY), Class I - General Controls.

Submitted by Inman Medical Corp. (Fort Worth, US). The FDA issued a Cleared decision on September 16, 1993 after a review of 79 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 Inman Medical Corp. devices

FDA 510(k) Submission Details - K933170

510(k) Number K933170 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1993
Decision Date September 16, 1993
Days to Decision 79 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 115d · This submission: 79d
Pathway characteristics
Predicate-based equivalence.

GCY Device Classification - Class 1, General Controls

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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