Cleared Traditional

K904667 - NA NEEDLES

K904667 is the FDA 510(k) clearance for NA NEEDLES by Olympus Corp.. It is a Class 1 General & Plastic Surgery device (product code GDM) cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K904667 · Olympus Corp. · General & Plastic Surgery device
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Dec 1990
Decision
58d
Days
Class 1
Risk

K904667 is an FDA 510(k) clearance for the NA NEEDLES. Classified as Needle, Aspiration And Injection, Reusable (product code GDM), Class I - General Controls.

Submitted by Olympus Corp. (Lake Success, US). The FDA issued a Cleared decision on December 12, 1990 after a review of 58 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 Olympus Corp. devices

Submission Details

510(k) Number K904667 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1990
Decision Date December 12, 1990
Days to Decision 58 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
57d faster than avg
Panel avg: 115d · This submission: 58d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GDM Needle, Aspiration And Injection, Reusable
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 - GDM Needle, Aspiration And Injection, Reusable

All 15
Devices cleared under the same product code (GDM) and FDA review panel - the closest regulatory comparables to K904667.
ILIAC CREST BONE MARROW ASPIRATION NEEDLE
K953082 · Baxter Healthcare Corp · Sep 1995
ILLINOIS STERNAL/ILIAC ASPIRATION NEEDLE
K930160 · Symbiosis Corp. · Jul 1993
BECTON DICKINSON MODIFIED MENGHINI NEEDLE
K915572 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1992
ISLAM STERNAL PUNCTURE NEEDLE, CAT # AG-592-00-U
K903747 · Downs Surgical , Ltd. · Oct 1990
ISLAM STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-V
K903748 · Downs Surgical , Ltd. · Oct 1990
ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-596-00-U
K903749 · Downs Surgical , Ltd. · Oct 1990