Cleared Traditional

K880881 - ARTUS DISPOSABLE SHEATHS/CUTTERS

K880881 is the FDA 510(k) clearance for ARTUS DISPOSABLE SHEATHS/CUTTERS by Acufex Microsurgical, Inc.. It is a Class 1 Orthopedic device (product code HSZ) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K880881 · Acufex Microsurgical, Inc. · Orthopedic device
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May 1988
Decision
63d
Days
Class 1
Risk

K880881 is an FDA 510(k) clearance for the ARTUS DISPOSABLE SHEATHS/CUTTERS. 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 May 4, 1988 after a review of 63 days - a notably fast clearance cycle.

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: 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 Acufex Microsurgical, Inc. devices

Submission Details

510(k) Number K880881 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1988
Decision Date May 04, 1988
Days to Decision 63 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
59d faster than avg
Panel avg: 122d · This submission: 63d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 31
Devices cleared under the same product code (HSZ) and FDA review panel - the closest regulatory comparables to K880881.
BONE HARVESTER SYSTEM & OSTEOTOME SYSTEM 2500
K900210 · Micro-Aire Surgical Instruments, Inc. · Feb 1990
INTERMEDICS POWER BROACH IMPACTOR
K895121 · Intermedics Orthopedics · Sep 1989
CONCEPT POWER SYSTEM
K881954 · Concept, Inc. · Nov 1988
ACE PNEUMATIC OSCILLATING SAW
K881250 · Buckman Co., Inc. · Apr 1988
MICRO-AIRE CEMENT REMOVAL TOOLS
K880324 · Micro-Aire Surgical Instruments, Inc. · Feb 1988
1.1 COUPLERS AND 1.2 ADAPTERS
K872550 · Micro-Aire Surgical Instruments, Inc. · Jul 1987