Cleared Traditional

K813000 - DISPOSABLE ARTHROSCOPY CANNULA SET

K813000 is an FDA 510(k) clearance for DISPOSABLE ARTHROSCOPY CANNULA SET, manufactured by Clinical Technology Corp.. The device is a Class 1 Orthopedic device with product code LXH cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K813000 · Clinical Technology Corp. · Orthopedic device
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Jan 1982
Decision
88d
Days
Class 1
Risk

K813000 is an FDA 510(k) clearance for the DISPOSABLE ARTHROSCOPY CANNULA SET. Classified as Orthopedic Manual Surgical Instrument (product code LXH), Class I - General Controls.

Submitted by Clinical Technology Corp. (Mchenry, US). The FDA issued a Cleared decision on January 22, 1982 after a review of 88 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 Clinical Technology Corp. devices

FDA 510(k) Submission Details - K813000

510(k) Number K813000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1981
Decision Date January 22, 1982
Days to Decision 88 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 122d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

LXH Device Classification - Class 1, General Controls

Product Code LXH Orthopedic Manual Surgical Instrument
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 - LXH Orthopedic Manual Surgical Instrument

All 29
Devices cleared under the same product code (LXH) and FDA review panel - the closest regulatory comparables to K813000.
MENISCAL SUTURING SYSTEM
K833943 · Dyonics, Inc. · Feb 1984
CRANE MENISCAL SUTURE SET
K834369 · Acufex Microsurgical, Inc. · Feb 1984
MULHOLLAN ARTHROSCOPIC NEEDLE CARRIER
K834370 · Acufex Microsurgical, Inc. · Feb 1984
HOWMEDICA KNEE BRUSH
K803127 · Howmedica Corp. · Feb 1981
FEMORAL CANAL BRUSH
K810267 · Richard'S Medical Equip., Inc. · Feb 1981
JACOB CHUCK
K802694 · Richard Wolf Medical Instruments Corp. · Nov 1980