Cleared Traditional

K933638 - ACUMED CARPAL TUNNEL RELEASE KIT

K933638 is the FDA 510(k) clearance for ACUMED CARPAL TUNNEL RELEASE KIT by Acu Med, Inc.. It is a Class 2 Orthopedic device (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

Submission Details

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.

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 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