Cleared Traditional

K801783 - CATHETER IRRIGATION TRAYS, #3300, 3310 & (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K801783 · The Healthcare Group Laboratories, Inc. · General & Plastic Surgery device
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Aug 1980
Decision
16d
Days
Class 2
Risk

K801783 is an FDA 510(k) clearance for the CATHETER IRRIGATION TRAYS, #3300, 3310 &. Classified as Tray, Irrigation, Sterile (product code EYN), Class II - Special Controls.

Submitted by The Healthcare Group Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 13, 1980 after a review of 16 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.5980 - 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 The Healthcare Group Laboratories, Inc. devices

Submission Details

510(k) Number K801783 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1980
Decision Date August 13, 1980
Days to Decision 16 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
98d faster than avg
Panel avg: 114d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EYN Tray, Irrigation, Sterile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
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 & Plastic Surgery devices follow this clearance model.