Cleared Traditional

ROBOTRAC (TM) RETRACTOR ARM

K893121 · Aesculap Instruments Corp. · General & Plastic Surgery
Jun 1989
Decision
37d
Days
Class 1
Risk

About This 510(k) Submission

K893121 is an FDA 510(k) clearance for the ROBOTRAC (TM) RETRACTOR ARM, a Retractor (Class I — General Controls, product code GAD), submitted by Aesculap Instruments Corp. (Burlingame, US). The FDA issued a Cleared decision on June 1, 1989, 37 days after receiving the submission on April 25, 1989. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K893121 FDA.gov
FDA Decision Cleared SESE
Date Received April 25, 1989
Decision Date June 01, 1989
Days to Decision 37 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code GAD — Retractor
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800