Cleared Traditional

K843925 - GILL'S IRRIGATOR/ASPIRATOR NEEDLE

K843925 is an FDA 510(k) clearance for GILL'S IRRIGATOR/ASPIRATOR NEEDLE, manufactured by Concept, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GAA cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K843925 · Concept, Inc. · General & Plastic Surgery device
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Nov 1984
Decision
31d
Days
Class 1
Risk

K843925 is an FDA 510(k) clearance for the GILL'S IRRIGATOR/ASPIRATOR NEEDLE. Classified as Needle, Aspiration And Injection, Disposable (product code GAA), Class I - General Controls.

Submitted by Concept, Inc. (Clearwater, US). The FDA issued a Cleared decision on November 5, 1984 after a review of 31 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 Concept, Inc. devices

FDA 510(k) Submission Details - K843925

510(k) Number K843925 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1984
Decision Date November 05, 1984
Days to Decision 31 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 115d · This submission: 31d
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 41
Devices cleared under the same product code (GAA) and FDA review panel - the closest regulatory comparables to K843925.
NAMIC CHIBA ASPIRATION BIOPSY NEEDLE
K864800 · North American Instrument Corp. · Feb 1987
HAWKIN NEEDLE
K851953 · Wilson-Cook Medical, Inc. · May 1985
CHIBA NEEDLE
K851957 · Wilson-Cook Medical, Inc. · May 1985
ISLAM BONE MARROW ASPIRATION NEEDLES
K842699 · Downs Surgical , Ltd. · Aug 1984
INTRADISCAL THERAPY NEEDLE 18 GAUGE
K840922 · Dlp, Inc. · Apr 1984
TRU-CUT BIOPSY/ASPIRA-NEEDLE 2N2709
K831392 · Travenol Laboratories, S.A. · Jul 1983