Cleared Traditional

K831392 - TRU-CUT BIOPSY/ASPIRA-NEEDLE 2N2709

K831392 is an FDA 510(k) clearance for TRU-CUT BIOPSY/ASPIRA-NEEDLE 2N2709, manufactured by Travenol Laboratories, S.A.. The device is a Class 1 General & Plastic Surgery device with product code GAA cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K831392 · Travenol Laboratories, S.A. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1983
Decision
74d
Days
Class 1
Risk

K831392 is an FDA 510(k) clearance for the TRU-CUT BIOPSY/ASPIRA-NEEDLE 2N2709. Classified as Needle, Aspiration And Injection, Disposable (product code GAA), Class I - General Controls.

Submitted by Travenol Laboratories, S.A. (Mchenry, US). The FDA issued a Cleared decision on July 12, 1983 after a review of 74 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.

FDA 510(k) Submission Details - K831392

510(k) Number K831392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1983
Decision Date July 12, 1983
Days to Decision 74 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
41d faster than avg
Panel avg: 115d · This submission: 74d
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 105
Devices cleared under the same product code (GAA) and FDA review panel - the closest regulatory comparables to K831392.
GARDNER TYPE BONE MARROW NEEDLE
K841301 · Popper & Sons, Inc. · Jun 1984
INTRADISCAL THERAPY NEEDLE 18 GAUGE
K840922 · Dlp, Inc. · Apr 1984
TOP STERILE DISPOS. HYPODERMIC NEEDLES
K832626 · Top Surgical Manufacturers Co. · Oct 1983
STERILE, DISPOSABLE, HYPODERMIC NEEDLES
K830378 · Abco Dealers, Inc. · Mar 1983
INJECTION ASPIRATING NEEDLES
K821697 · American Endoscopy, Inc. · Jun 1982
VARIOUS STERILE BIOPSY ASPIRATION NEED
K821017 · Medsurg Industries, Inc. · Jun 1982
K831392 · TRU-CUT BIOPSY/ASPIRA-NEEDLE 2N2709
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