Cleared Traditional

K930160 - ILLINOIS STERNAL/ILIAC ASPIRATION NEEDLE

K930160 is an FDA 510(k) clearance for ILLINOIS STERNAL/ILIAC ASPIRATION NEEDLE, manufactured by Symbiosis Corp.. The device is a Class 1 General & Plastic Surgery device with product code GDM cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K930160 · Symbiosis Corp. · General & Plastic Surgery device
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Jul 1993
Decision
174d
Days
Class 1
Risk

K930160 is an FDA 510(k) clearance for the ILLINOIS STERNAL/ILIAC ASPIRATION NEEDLE. Classified as Needle, Aspiration And Injection, Reusable (product code GDM), Class I - General Controls.

Submitted by Symbiosis Corp. (Miami, US). The FDA issued a Cleared decision on July 6, 1993 after a review of 174 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Symbiosis Corp. devices

FDA 510(k) Submission Details - K930160

510(k) Number K930160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1993
Decision Date July 06, 1993
Days to Decision 174 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
59d slower than avg
Panel avg: 115d · This submission: 174d
Pathway characteristics
Predicate-based equivalence.

GDM Device Classification - Class 1, General Controls

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 K930160.
ILIAC CREST BONE MARROW ASPIRATION NEEDLE
K953082 · Baxter Healthcare Corp · Sep 1995
BECTON DICKINSON MODIFIED MENGHINI NEEDLE
K915572 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1992
NA NEEDLES
K904667 · Olympus Corp. · Dec 1990
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