Cleared Traditional

K844094 - PRUITT IRRIGATION AND OCCLUSION CATHETER

K844094 is an FDA 510(k) clearance for PRUITT IRRIGATION AND OCCLUSION CATHETER, manufactured by Bionomy, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GBX cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K844094 · Bionomy, Inc. · General & Plastic Surgery device
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Nov 1984
Decision
42d
Days
Class 1
Risk

K844094 is an FDA 510(k) clearance for the PRUITT IRRIGATION AND OCCLUSION CATHETER. Classified as Catheter, Irrigation (product code GBX), Class I - General Controls.

Submitted by Bionomy, Inc. (Tampa, US). The FDA issued a Cleared decision on November 29, 1984 after a review of 42 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4200 - 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 Bionomy, Inc. devices

FDA 510(k) Submission Details - K844094

510(k) Number K844094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1984
Decision Date November 29, 1984
Days to Decision 42 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
73d faster than avg
Panel avg: 115d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

GBX Device Classification - Class 1, General Controls

Product Code GBX Catheter, Irrigation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4200
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 - GBX Catheter, Irrigation

All 50
Devices cleared under the same product code (GBX) and FDA review panel - the closest regulatory comparables to K844094.
CLOSED PARACENTESIS SYSTEM W/BOASBERG CATHETER SET
K870704 · American Pharmaseal Div. Ahsc · Mar 1987
MICROTEK IRRIGATION SYSTEM
K844061 · Microtek Medical, Inc. · May 1985
VYGON CANNULA FOR SURGICAL SUCTION YAN KAUER 574/5
K851475 · Vygon Corp. · May 1985
TIDAL DISTENSION IRRIGATION SET
K841362 · Abbott Laboratories · Aug 1984
ARTHROSCOPIC IRRIGATION SETS-2C4030/31
K823496 · Travenol Laboratories, S.A. · Dec 1982
IRRIGATION CATHETER
K780788 · Shiley, Inc. · Jun 1978