Cleared Traditional

K922557 - ACUFEX ARTHROSCOPIC CARPAL TUNNEL RELEASE KIT

K922557 is an FDA 510(k) clearance for ACUFEX ARTHROSCOPIC CARPAL TUNNEL RELEA..., manufactured by Acufex Microsurgical, Inc.. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K922557

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.

HRX Device Classification - Class 2, Special Controls

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 521
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
DOUGLAS MEDICAL PRODUCTS, INC. IRRIGATION SET
K922318 · Douglas Medical Products Corp. · Aug 1992
INTEGRATED ENDOSCOPY SYSTEM 1000
K920800 · Biomet, Inc. · Jun 1992