Cleared Traditional

K844130 - ACUFEX ARTHROSCOPIC SHAVER

K844130 is an FDA 510(k) clearance for ACUFEX ARTHROSCOPIC SHAVER, manufactured by Acufex Microsurgical, Inc.. The device is a Class 1 Orthopedic device with product code HSZ cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K844130 · Acufex Microsurgical, Inc. · Orthopedic device
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Mar 1985
Decision
149d
Days
Class 1
Risk

K844130 is an FDA 510(k) clearance for the ACUFEX ARTHROSCOPIC SHAVER. Classified as Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment (product code HSZ), Class I - General Controls.

Submitted by Acufex Microsurgical, Inc. (Norwood, US). The FDA issued a Cleared decision on March 21, 1985 after a review of 149 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.4820 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Acufex Microsurgical, Inc. devices

FDA 510(k) Submission Details - K844130

510(k) Number K844130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1984
Decision Date March 21, 1985
Days to Decision 149 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 122d · This submission: 149d
Pathway characteristics
Predicate-based equivalence.

HSZ Device Classification - Class 1, General Controls

Product Code HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4820
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 - HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment

All 35
Devices cleared under the same product code (HSZ) and FDA review panel - the closest regulatory comparables to K844130.
EFTEKHAR RECHANNELIZATION DRILL GUIDE
K864314 · The Anspach Effort, Inc. · Nov 1986
REPLACEMENT HOSES
K861405 · Micro-Aire Surgical Instruments, Inc. · Apr 1986
MICRO-AIRE OSCILLATING SAW, 1740-000 & WIRE DRIVER
K851443 · Micro-Aire Surgical Instruments, Inc. · May 1985
NUCLEOTOME
K844131 · Medical Instrument Development Laboratories, Inc. · Nov 1984
ENDOTOME PNEUMATIC ORTHOPAEDIC CUT
K840831 · Cabot Medical Corp. · Apr 1984
ANSPACH 65,000
K831756 · The Anspach Effort, Inc. · Sep 1983