Cleared Traditional

K913992 - ASPIRATION/INJECTION NEEDLE

K913992 is an FDA 510(k) clearance for ASPIRATION/INJECTION NEEDLE, manufactured by Northgate Technologies, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GAA cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K913992 · Northgate Technologies, Inc. · General & Plastic Surgery device
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Oct 1991
Decision
55d
Days
Class 1
Risk

K913992 is an FDA 510(k) clearance for the ASPIRATION/INJECTION NEEDLE. Classified as Needle, Aspiration And Injection, Disposable (product code GAA), Class I - General Controls.

Submitted by Northgate Technologies, Inc. (Arlington Heights, US). The FDA issued a Cleared decision on October 30, 1991 after a review of 55 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 Northgate Technologies, Inc. devices

FDA 510(k) Submission Details - K913992

510(k) Number K913992 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1991
Decision Date October 30, 1991
Days to Decision 55 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 115d · This submission: 55d
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 72
Devices cleared under the same product code (GAA) and FDA review panel - the closest regulatory comparables to K913992.
TURKEL THORACENTESIS SYSTEM
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KOPAN'S TARGET
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BREAST LES LOCAL WIRE ST. 48219/49220/48119/48120
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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