Cleared Traditional

K910975 - TEKDYNE MICRO RETRACTOR

K910975 is an FDA 510(k) clearance for TEKDYNE MICRO RETRACTOR, manufactured by Tekdyne. The device is a Class 1 General & Plastic Surgery device with product code GAD cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K910975 · Tekdyne · General & Plastic Surgery device
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Apr 1991
Decision
25d
Days
Class 1
Risk

K910975 is an FDA 510(k) clearance for the TEKDYNE MICRO RETRACTOR. Classified as Retractor (product code GAD), Class I - General Controls.

Submitted by Tekdyne (Quakertown, US). The FDA issued a Cleared decision on April 1, 1991 after a review of 25 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 Tekdyne devices

FDA 510(k) Submission Details - K910975

510(k) Number K910975 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1991
Decision Date April 01, 1991
Days to Decision 25 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
90d faster than avg
Panel avg: 115d · This submission: 25d
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 62
Devices cleared under the same product code (GAD) and FDA review panel - the closest regulatory comparables to K910975.
THOROCOSCOPY SELF-RETAINING RETRACTOR
K926585 · T. Korossurgical Instruments Corp. · Aug 1993
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