Cleared Traditional

K933638 - ACUMED CARPAL TUNNEL RELEASE KIT

K933638 is an FDA 510(k) clearance for ACUMED CARPAL TUNNEL RELEASE KIT, manufactured by Acu Med, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K933638 · Acu Med, Inc. · Orthopedic device
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Mar 1994
Decision
240d
Days
Class 2
Risk

K933638 is an FDA 510(k) clearance for the ACUMED CARPAL TUNNEL RELEASE KIT. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Acu Med, Inc. (Beaverton, US). The FDA issued a Cleared decision on March 24, 1994 after a review of 240 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 Acu Med, Inc. devices

FDA 510(k) Submission Details - K933638

510(k) Number K933638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1993
Decision Date March 24, 1994
Days to Decision 240 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
118d slower than avg
Panel avg: 122d · This submission: 240d
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 K933638.
MOD. PERCUTANEOUS ARTHROSCOPIC MICRO DISCECTOMY
K922519 · Smith & Nephew, Inc. · Mar 1994
AUTO SUTURE DISPOSABLE ARTHROSCOPIC TROCAR AND SLEEVE
K934720 · United States Surgical, A Division of Tyco Healthc · Mar 1994
ARTHTOTEK PRECISION HAND INSTRUMENTATION
K933070 · Biomet, Inc. · Mar 1994
ARTHROTEK CANNULA SYSTEM
K934401 · Biomet, Inc. · Mar 1994
ACUFEX ADJUSTABLE-LENGTH CANNULA
K934181 · Acufex Microsurgical, Inc. · Mar 1994
GORE SMOOTHER CRUCIAL TOOL
K936206 · W.L. Gore & Associates, Inc. · Mar 1994