Cleared Traditional

K925573 - ACUFEX T-BAR

K925573 is the FDA 510(k) clearance for ACUFEX T-BAR by Acufex Microsurgical, Inc.. It is a Class 2 Orthopedic device (product code HRX) cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K925573 · Acufex Microsurgical, Inc. · Orthopedic device
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May 1993
Decision
183d
Days
Class 2
Risk

K925573 is an FDA 510(k) clearance for the ACUFEX T-BAR. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Acufex Microsurgical, Inc. (Mansfield, US). The FDA issued a Cleared decision on May 5, 1993 after a review of 183 days - an extended review cycle.

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 K925573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1992
Decision Date May 05, 1993
Days to Decision 183 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
61d slower than avg
Panel avg: 122d · This submission: 183d
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 K925573.
ARTHREX INSTRUMENTS (WRIST)
K926303 · Arthrex, Inc. · Jan 1994
ACUFEX PRO-PAC AND ISO-PAC
K931621 · Acufex Microsurgical, Inc. · Jan 1994
RESTORE TUNNEL PLUG
K923069 · Depuy, Inc. · Jun 1993
ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM (CTR)
K924144 · Davol, Inc. · Apr 1993
DANEKSCOPE AND ACCESSORIES
K911729 · Danek Medical, Inc. · Apr 1993
ARTHROSCOPIC ACL CANNULATED DRILLS AND SLEEVES
K925996 · Arthrex, Inc. · Mar 1993