Cleared Traditional

K934181 - ACUFEX ADJUSTABLE-LENGTH CANNULA

K934181 is the FDA 510(k) clearance for ACUFEX ADJUSTABLE-LENGTH CANNULA by Acufex Microsurgical, Inc.. It is a Class 2 Orthopedic device (product code HRX) cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K934181 · Acufex Microsurgical, Inc. · Orthopedic device
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Mar 1994
Decision
209d
Days
Class 2
Risk

K934181 is an FDA 510(k) clearance for the ACUFEX ADJUSTABLE-LENGTH CANNULA. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Acufex Microsurgical, Inc. (Mansfield, US). The FDA issued a Cleared decision on March 23, 1994 after a review of 209 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 K934181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1993
Decision Date March 23, 1994
Days to Decision 209 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
87d slower than avg
Panel avg: 122d · This submission: 209d
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 K934181.
ARTHTOTEK PRECISION HAND INSTRUMENTATION
K933070 · Biomet, Inc. · Mar 1994
ACUMED CARPAL TUNNEL RELEASE KIT
K933638 · Acu Med, Inc. · Mar 1994
ARTHROTEK CANNULA SYSTEM
K934401 · Biomet, Inc. · Mar 1994
GORE SMOOTHER CRUCIAL TOOL
K936206 · W.L. Gore & Associates, Inc. · Mar 1994
ACUFEX MENISCAL RASPS
K932460 · Acufex Microsurgical, Inc. · Mar 1994
ACUFEX METAL ACL CANNULA
K932718 · Acufex Microsurgical, Inc. · Mar 1994