Cleared Traditional

K910117 - REDDICK IRRIGATION/ASPIRATION SYSTEM

K910117 is an FDA 510(k) clearance for REDDICK IRRIGATION/ASPIRATION SYSTEM, manufactured by Ideal Medical, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GAA cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K910117 · Ideal Medical, Inc. · General & Plastic Surgery device
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Mar 1991
Decision
67d
Days
Class 1
Risk

K910117 is an FDA 510(k) clearance for the REDDICK IRRIGATION/ASPIRATION SYSTEM. Classified as Needle, Aspiration And Injection, Disposable (product code GAA), Class I - General Controls.

Submitted by Ideal Medical, Inc. (Clearwater, US). The FDA issued a Cleared decision on March 19, 1991 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 878.4800 - 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 Ideal Medical, Inc. devices

FDA 510(k) Submission Details - K910117

510(k) Number K910117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1991
Decision Date March 19, 1991
Days to Decision 67 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
48d faster than avg
Panel avg: 115d · This submission: 67d
Pathway characteristics
Predicate-based equivalence.

GAA Device Classification - Class 1, General Controls

Product Code GAA Needle, Aspiration And Injection, Disposable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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 - GAA Needle, Aspiration And Injection, Disposable

All 73
Devices cleared under the same product code (GAA) and FDA review panel - the closest regulatory comparables to K910117.
ASPIRATION/INJECTION NEEDLE
K913992 · Northgate Technologies, Inc. · Oct 1991
BONE MARROW BIOPSY TRAY
K912074 · Manan Medical Products, Inc. · Aug 1991
SURG TECH,INC. 30 GAUGE STRAIGHT EXTRUSION NEEDLES
K910036 · Surgical Technologies, Inc. · Apr 1991
SURE-STOP TRANSBRONCHIAL ASPIRATION NEEDLE
K901438 · Telemed Systems, Inc. · May 1990
WILSON-COOK LUNG BIOPSY NEEDLE
K897050 · Wilson-Cook Medical, Inc. · Apr 1990
MODIFIED DISP. CHIBA-TYPE NEEDLE DESIGNATED ASPI.
K896019 · Dlp, Inc. · Jan 1990