Cleared Traditional

K890261 - TRIGEMINAL SCISSORS

K890261 is an FDA 510(k) clearance for TRIGEMINAL SCISSORS, manufactured by Kinetic Medical Products. The device is a Class 1 Orthopedic device with product code HRR cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K890261 · Kinetic Medical Products · Orthopedic device
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Jan 1989
Decision
9d
Days
Class 1
Risk

K890261 is an FDA 510(k) clearance for the TRIGEMINAL SCISSORS. Classified as Scissors, Orthopedic, Surgical (product code HRR), 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 Orthopedic FDA review panel, regulated under 21 CFR 888.4540 - the FDA orthopedic device regulatory 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 - K890261

510(k) Number K890261 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 Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 122d · This submission: 9d
Pathway characteristics
Predicate-based equivalence.

HRR Device Classification - Class 1, General Controls

Product Code HRR Scissors, Orthopedic, Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.4540
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 - HRR Scissors, Orthopedic, Surgical

Devices cleared under the same product code (HRR) and FDA review panel - the closest regulatory comparables to K890261.
MICROSURGICAL SCISSORS
K890212 · Kinetic Medical Products · Jan 1989
SURGICAL SCISSORS
K890225 · Kinetic Medical Products · Jan 1989
SCISSOR, LEFT
K873501 · Arthropedics, Inc. · Nov 1987
SCISSOR, RIGHT
K873502 · Arthropedics, Inc. · Nov 1987
69-100 TO 69-114 VARIOUS CUTICLE SCISSORS
K851800 · Artiberia · Jun 1985
GENERAL UTILITY SURG. SCISSORS #460180-
K800721 · Edward Weck, Inc. · May 1980