Cleared Traditional

ILLINOIS STERNAL/ILIAC ASPIRATION NEEDLE

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

About This 510(k) Submission

K930160 is an FDA 510(k) clearance for the ILLINOIS STERNAL/ILIAC ASPIRATION NEEDLE, a Needle, Aspiration And Injection, Reusable (Class I — General Controls, product code GDM), submitted by Symbiosis Corp. (Miami, US). The FDA issued a Cleared decision on July 6, 1993, 174 days after receiving the submission on January 13, 1993. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K930160 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code GDM — Needle, Aspiration And Injection, Reusable
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800