Cleared Traditional

K830378 - STERILE

K830378 is the FDA 510(k) clearance for STERILE by Abco Dealers, Inc.. It is a Class 1 General & Plastic Surgery device (product code GAA) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K830378 · Abco Dealers, Inc. · General & Plastic Surgery device
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Mar 1983
Decision
48d
Days
Class 1
Risk

K830378 is an FDA 510(k) clearance for the STERILE, DISPOSABLE, HYPODERMIC NEEDLES. Classified as Needle, Aspiration And Injection, Disposable (product code GAA), Class I - General Controls.

Submitted by Abco Dealers, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 24, 1983 after a review of 48 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 Abco Dealers, Inc. devices

Submission Details

510(k) Number K830378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1983
Decision Date March 24, 1983
Days to Decision 48 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
67d faster than avg
Panel avg: 115d · This submission: 48d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 29
Devices cleared under the same product code (GAA) and FDA review panel - the closest regulatory comparables to K830378.
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
VARIOUS STERILE BIOPSY ASPIRATION NEED
K821017 · Medsurg Industries, Inc. · Jun 1982
HYPODERMIC NEEDLES & SYRINGES
K821348 · Medi-Tech, Inc. · Jun 1982
CUATICO MYELOGRAPHY NEEDLES
K813367 · Dlp, Inc. · Jan 1982