Cleared Traditional

K893121 - ROBOTRAC (TM) RETRACTOR ARM

K893121 is an FDA 510(k) clearance for ROBOTRAC (TM) RETRACTOR ARM, manufactured by Aesculap Instruments Corp.. The device is a Class 1 General & Plastic Surgery device with product code GAD cleared through the Traditional 510(k) pathway after a 37-day FDA review.

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

K893121 is an FDA 510(k) clearance for the ROBOTRAC (TM) RETRACTOR ARM. Classified as Retractor (product code GAD), Class I - General Controls.

Submitted by Aesculap Instruments Corp. (Burlingame, US). The FDA issued a Cleared decision on June 1, 1989 after a review of 37 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Aesculap Instruments Corp. devices

FDA 510(k) Submission Details - K893121

510(k) Number K893121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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 -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 115d · This submission: 37d
Pathway characteristics
Predicate-based equivalence.

GAD Device Classification - Class 1, General Controls

Product Code GAD Retractor
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 - GAD Retractor

All 61
Devices cleared under the same product code (GAD) and FDA review panel - the closest regulatory comparables to K893121.
AUTO SUTURE(R) ENDOSCOPIC FAN RETRACTOR
K914190 · United States Surgical, A Division of Tyco Healthc · May 1992
SUREBREATH DOME, E-Z BREATHER
K915158 · Ipax, Inc. · Feb 1992
SUCTION RETRACTOR(TOWER ATTACH.)FOR CRANK FRAM RET
K903969 · Karlin Technology, Inc. · Sep 1990
ROLLET RETRACTOR
K891892 · Zinnanti Surgical Instruments, Inc. · Apr 1989
KIRSCHNER RETRACTOR
K891031 · Zinnanti Surgical Instruments, Inc. · Apr 1989
SURGICAL RETRACTORS
K890247 · Kinetic Medical Products · Jan 1989