Cleared Traditional

K922557 - ACUFEX ARTHROSCOPIC CARPAL TUNNEL RELEA...

K922557 is the FDA 510(k) clearance for ACUFEX ARTHROSCOPIC CARPAL TUNNEL RELEA... by Acufex Microsurgical, Inc.. It is a Class 2 Orthopedic device (product code HRX) cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K922557 · Acufex Microsurgical, Inc. · Orthopedic device
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Sep 1992
Decision
111d
Days
Class 2
Risk

K922557 is an FDA 510(k) clearance for the ACUFEX ARTHROSCOPIC CARPAL TUNNEL RELEASE KIT. 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 17, 1992 after a review of 111 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 K922557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1992
Decision Date September 17, 1992
Days to Decision 111 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 122d · This submission: 111d
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 K922557.
ARTHREX KNEE ARTHROSCOPIC SURGERY ACCESSORIES
K922890 · Arthrex, Inc. · Feb 1993
ARTHREX ATRAUMATIC MINI-GRASPER
K925455 · Arthrex, Inc. · Feb 1993
ARTHREX ARTHROSCOPY ICE BLADE
K921823 · Arthrex, Inc. · Oct 1992
CLEARTRAC CANNULA
K920454 · Acufex Microsurgical, Inc. · Sep 1992
INTEGRATED ENDOSCOPY SYSTEM 1000
K920800 · Biomet, Inc. · Jun 1992
MODEL AR-6300 INFUSION PUMP
K915721 · Arthrex, Inc. · Mar 1992