Cleared Traditional

K891894 - ELEVATORS-COTTLE

K891894 is the FDA 510(k) clearance for ELEVATORS-COTTLE by Zinnanti Surgical Instruments, Inc.. It is a Class 1 General & Plastic Surgery device (product code GEG) cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K891894 · Zinnanti Surgical Instruments, Inc. · General & Plastic Surgery device
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Apr 1989
Decision
19d
Days
Class 1
Risk

K891894 is an FDA 510(k) clearance for the ELEVATORS-COTTLE,MCKENTY,GOLDMAN,JOSEPH,CONVERSE. Classified as Elevator, Surgical, General & Plastic Surgery (product code GEG), Class I - General Controls.

Submitted by Zinnanti Surgical Instruments, Inc. (Chatsworth, US). The FDA issued a Cleared decision on April 12, 1989 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 Zinnanti Surgical Instruments, Inc. devices

Submission Details

510(k) Number K891894 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1989
Decision Date April 12, 1989
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.

Device Classification

Product Code GEG Elevator, Surgical, General & Plastic Surgery
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 - GEG Elevator, Surgical, General & Plastic Surgery

All 9
Devices cleared under the same product code (GEG) and FDA review panel - the closest regulatory comparables to K891894.
ELEVATORS, VARIOUS TYPES
K891899 · Zinnanti Surgical Instruments, Inc. · Apr 1989
SEPTUM ELEVATOR
K890365 · Kinetic Medical Products · Feb 1989
LIGATURE NEEDLES
K890230 · Kinetic Medical Products · Jan 1989
SURGICAL ELEVATOR
K890253 · Kinetic Medical Products · Jan 1989
1.1 TWIST DRILLS AND 1.2 CORTICAL DRILLS
K872491 · Micro-Aire Surgical Instruments, Inc. · Jul 1987
ACROMED WALLIE-HEINIG DISECTOR/ELEVATORS
K870781 · Buckman Co., Inc. · Mar 1987