Cleared Traditional

K843208 - ACUFEX ARTHROSCOPE

K843208 is the FDA 510(k) clearance for ACUFEX ARTHROSCOPE by Acufex Microsurgical, Inc.. It is a Class 2 Orthopedic device (product code HRX) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K843208 · Acufex Microsurgical, Inc. · Orthopedic device
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Sep 1984
Decision
27d
Days
Class 2
Risk

K843208 is an FDA 510(k) clearance for the ACUFEX ARTHROSCOPE. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Acufex Microsurgical, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 11, 1984 after a review of 27 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Acufex Microsurgical, Inc. devices

Submission Details

510(k) Number K843208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1984
Decision Date September 11, 1984
Days to Decision 27 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 122d · This submission: 27d
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 K843208.
AMERICAN EDWARDS SMALL DIAMETER RIGID ENDOSCOPE
K851374 · American Edwards Laboratories · Jun 1985
CODMAN ARTHROSCOPE
K851229 · Codman & Shurtleff, Inc. · May 1985
RICHARD ARTHROSCOPE
K843604 · Richards Medical Co., Inc. · Oct 1984
AMERICAN EDWARDS LABS FLEXISCOPE
K841607 · American Edwards Laboratories · Aug 1984
AMER. EDWARDS LAB FLEXISCOPE OBTURATOR
K842323 · American Edwards Laboratories · Aug 1984
ANTHROSCOPY SYSTEM
K834146 · Cabot Medical Corp. · Mar 1984