Cleared Traditional

K896589 - MANUAL SURGICAL INSTRUMENTS FOR TITAMED ANTWERP
(FDA 510(k) Clearance)

K896589 · Optik · General & Plastic Surgery
Dec 1989
Decision
36d
Days
Class 1
Risk

K896589 is an FDA 510(k) clearance for the MANUAL SURGICAL INSTRUMENTS FOR TITAMED ANTWERP, a Screwdriver, Surgical (Class I — General Controls, product code LRZ), submitted by Optik (Criftib, US). The FDA issued a Cleared decision on December 27, 1989, 36 days after receiving the submission on November 21, 1989. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K896589 FDA.gov
FDA Decision Cleared SESE
Date Received November 21, 1989
Decision Date December 27, 1989
Days to Decision 36 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code LRZ — Screwdriver, Surgical
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800