Cleared Traditional

K890264 - STRABISMUS SCISSORS

K890264 is an FDA 510(k) clearance for STRABISMUS SCISSORS, manufactured by Kinetic Medical Products. The device is a Class 1 General & Plastic Surgery device with product code LRW cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K890264 · Kinetic Medical Products · General & Plastic Surgery device
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Jan 1989
Decision
9d
Days
Class 1
Risk

K890264 is an FDA 510(k) clearance for the STRABISMUS SCISSORS. Classified as Scissors, General, Surgical (product code LRW), Class I - General Controls.

Submitted by Kinetic Medical Products (Erie, US). The FDA issued a Cleared decision on January 27, 1989 after a review of 9 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 Kinetic Medical Products devices

FDA 510(k) Submission Details - K890264

510(k) Number K890264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1989
Decision Date January 27, 1989
Days to Decision 9 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
106d faster than avg
Panel avg: 115d · This submission: 9d
Pathway characteristics
Predicate-based equivalence.

LRW Device Classification - Class 1, General Controls

Product Code LRW Scissors, General, Surgical
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 - LRW Scissors, General, Surgical

All 10
Devices cleared under the same product code (LRW) and FDA review panel - the closest regulatory comparables to K890264.
RIBBON TYPE SCISSORS: TENOTOMY,IRIS,EYE,STRABISMUS
K891200 · Zinnanti Surgical Instruments, Inc. · Apr 1989
SCISSORS: THOREK, JORGENSEN, FINOCHIETTO
K891203 · Zinnanti Surgical Instruments, Inc. · Apr 1989
DRESSING SCISSORS
K890235 · Kinetic Medical Products · Feb 1989
MICRO SCISSOR, 1.7MM
K871923 · Arthropedics, Inc. · Jun 1987
69-120 TO 69-132 VARIOUS NAIL SCISSORS
K851801 · Artiberia · Jun 1985
69-140 TO 69-160 VARIOUS NAIL CUTTERS
K851802 · Artiberia · Jun 1985