Cleared Traditional

K884095 - SCISSORS, WIRE CUTTING

K884095 is an FDA 510(k) clearance for SCISSORS, manufactured by Magnatrade Corp.. The device is a Class 1 General & Plastic Surgery device with product code LRW cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K884095 · Magnatrade Corp. · General & Plastic Surgery device
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Oct 1988
Decision
21d
Days
Class 1
Risk

K884095 is an FDA 510(k) clearance for the SCISSORS, WIRE CUTTING. Classified as Scissors, General, Surgical (product code LRW), Class I - General Controls.

Submitted by Magnatrade Corp. (Tulsa, US). The FDA issued a Cleared decision on October 19, 1988 after a review of 21 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 Magnatrade Corp. devices

FDA 510(k) Submission Details - K884095

510(k) Number K884095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1988
Decision Date October 19, 1988
Days to Decision 21 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
94d faster than avg
Panel avg: 115d · This submission: 21d
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 13
Devices cleared under the same product code (LRW) and FDA review panel - the closest regulatory comparables to K884095.
SCISSORS: THOREK, JORGENSEN, FINOCHIETTO
K891203 · Zinnanti Surgical Instruments, Inc. · Apr 1989
DRESSING SCISSORS
K890235 · Kinetic Medical Products · Feb 1989
STRABISMUS SCISSORS
K890264 · Kinetic Medical Products · Jan 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