Cleared Traditional

K881157 - STERNUM SPREADER AND MITRAL VALVE RETRACTOR

K881157 is an FDA 510(k) clearance for STERNUM SPREADER AND MITRAL VALVE RETRACTOR, manufactured by T. Korossurgical 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 19-day FDA review.

K881157 · T. Korossurgical Instruments Corp. · General & Plastic Surgery device
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Apr 1988
Decision
19d
Days
Class 1
Risk

K881157 is an FDA 510(k) clearance for the STERNUM SPREADER AND MITRAL VALVE RETRACTOR. Classified as Retractor (product code GAD), Class I - General Controls.

Submitted by T. Korossurgical Instruments Corp. (Moorepark, US). The FDA issued a Cleared decision on April 6, 1988 after a review of 19 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 T. Korossurgical Instruments Corp. devices

FDA 510(k) Submission Details - K881157

510(k) Number K881157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1988
Decision Date April 06, 1988
Days to Decision 19 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 115d · This submission: 19d
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 46
Devices cleared under the same product code (GAD) and FDA review panel - the closest regulatory comparables to K881157.
SURGICAL RETRACTORS
K890247 · Kinetic Medical Products · Jan 1989
SURGICAL RETRACTORS
K890248 · Kinetic Medical Products · Jan 1989
SURGICAL WIRE CUTTERS
K890250 · Kinetic Medical Products · Jan 1989
UNIVERSAL STERNUM SPREADER AND I.M.A. RETRACTOR
K881156 · T. Korossurgical Instruments Corp. · Apr 1988
I.M.A. RETRACTOR
K881159 · T. Korossurgical Instruments Corp. · Apr 1988
SPRING RETRACTOR
K880997 · T. Korossurgical Instruments Corp. · Mar 1988