Cleared Traditional

K911238 - TAHOE SUCTION IRRIGATOR

K911238 is an FDA 510(k) clearance for TAHOE SUCTION IRRIGATOR, manufactured by Tahoe Pro Instruments. The device is a Class 2 General Hospital device with product code GCX cleared through the Traditional 510(k) pathway after a 618-day FDA review.

K911238 · Tahoe Pro Instruments · General Hospital
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Nov 1992
Decision
618d
Days
Class 2
Risk

K911238 is an FDA 510(k) clearance for the TAHOE SUCTION IRRIGATOR. Classified as Apparatus, Suction, Operating-room, Wall Vacuum Powered (product code GCX), Class II - Special Controls.

Submitted by Tahoe Pro Instruments (So. Lake Tahoe, US). The FDA issued a Cleared decision on November 27, 1992 after a review of 618 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6740 - the FDA general hospital 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Tahoe Pro Instruments devices

FDA 510(k) Submission Details - K911238

510(k) Number K911238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1991
Decision Date November 27, 1992
Days to Decision 618 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
489d slower than avg
Panel avg: 129d · This submission: 618d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCX Device Classification - Class 2, Special Controls

Product Code GCX Apparatus, Suction, Operating-room, Wall Vacuum Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6740
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - GCX Apparatus, Suction, Operating-room, Wall Vacuum Powered

All 58
Devices cleared under the same product code (GCX) and FDA review panel - the closest regulatory comparables to K911238.
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