Cleared Traditional

NEEDLE EXTENSIONS

K891035 · Zinnanti Surgical Instruments, Inc. · Obstetrics & Gynecology
Mar 1989
Decision
22d
Days
Class 1
Risk

About This 510(k) Submission

K891035 is an FDA 510(k) clearance for the NEEDLE EXTENSIONS, a Instrument, Manual, General Obstetric-gynecologic (Class I — General Controls, product code KOH), submitted by Zinnanti Surgical Instruments, Inc. (Chatsworth, US). The FDA issued a Cleared decision on March 22, 1989, 22 days after receiving the submission on February 28, 1989. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4520.

Submission Details

510(k) Number K891035 FDA.gov
FDA Decision Cleared SESE
Date Received February 28, 1989
Decision Date March 22, 1989
Days to Decision 22 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary —

Device Classification

Product Code KOH — Instrument, Manual, General Obstetric-gynecologic
Device Class Class I — General Controls
CFR Regulation 21 CFR 884.4520

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