Cleared Traditional

K942834 - ACUFEX UNI-CUT 4. OMM CARPAL TUNNEL CAN...

K942834 is the FDA 510(k) clearance for ACUFEX UNI-CUT 4. OMM CARPAL TUNNEL CAN... by Acufex Microsurgical, Inc.. It is a Class 2 Orthopedic device (product code HRX) cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K942834 · Acufex Microsurgical, Inc. · Orthopedic device
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Sep 1994
Decision
105d
Days
Class 2
Risk

K942834 is an FDA 510(k) clearance for the ACUFEX UNI-CUT 4. OMM CARPAL TUNNEL CANNULA. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Acufex Microsurgical, Inc. (Mansfield, US). The FDA issued a Cleared decision on September 28, 1994 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.1100 - 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

Submission Details

510(k) Number K942834 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1994
Decision Date September 28, 1994
Days to Decision 105 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 122d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRX Arthroscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.1100
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HRX Arthroscope

All 361
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K942834.
ACUFEX ACL SHEATH FOR INTERFERENCE SCREWS
K940290 · Acufex Microsurgical, Inc. · Sep 1994
CURVED ROTATABLE DISPOSABLE ARTHROSCOPIC SURGERY BLADES
K941036 · Smith & Nephew, Inc. · Sep 1994
MANUAL SURGICAL INSTRUMENTS
K942079 · Acufex Microsurgical, Inc. · Sep 1994
ACUFEX(R) ENDO-FEMORAL AIMER
K942846 · Acufex Microsurgical, Inc. · Sep 1994
REVO ROTATOR CUFF REPAIR SYSTEM
K941691 · Linvatec Corp. · Sep 1994
CARPAL TUNNEL SYSTEM
K940234 · Richard Wolf Medical Instruments Corp. · Aug 1994