Cleared Traditional

K932090 - ACUFEX DISPOSABLE MENISCAL CANNULA

K932090 is the FDA 510(k) clearance for ACUFEX DISPOSABLE MENISCAL CANNULA by Acufex Microsurgical, Inc.. It is a Class 2 Orthopedic device (product code HRX) cleared through the Traditional 510(k) pathway after a 424-day FDA review.

K932090 · Acufex Microsurgical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1994
Decision
424d
Days
Class 2
Risk

K932090 is an FDA 510(k) clearance for the ACUFEX DISPOSABLE MENISCAL 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 June 28, 1994 after a review of 424 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Acufex Microsurgical, Inc. devices

Submission Details

510(k) Number K932090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1993
Decision Date June 28, 1994
Days to Decision 424 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
302d slower than avg
Panel avg: 122d · This submission: 424d
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 K932090.
REVO ROTATOR CUFF REPAIR SYSTEM
K941691 · Linvatec Corp. · Sep 1994
CARPAL TUNNEL SYSTEM
K940234 · Richard Wolf Medical Instruments Corp. · Aug 1994
SMITH AND NEPHEW SPINE DEFLECTING FORCEPS
K940222 · Smith & Nephew, Inc. · Jun 1994
ACUMED FLEXIBLE CANNULA
K932099 · Acu Med, Inc. · Jun 1994
ARTHROSCOPE
K940090 · Richard Wolf Medical Instruments Corp. · Jun 1994
POLY BLADES
K940515 · Linvatec Corp. · May 1994