Cleared Traditional

K843604 - RICHARD ARTHROSCOPE

K843604 is an FDA 510(k) clearance for RICHARD ARTHROSCOPE, manufactured by Richards Medical Co., Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K843604 · Richards Medical Co., Inc. · Orthopedic device
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Oct 1984
Decision
39d
Days
Class 2
Risk

K843604 is an FDA 510(k) clearance for the RICHARD ARTHROSCOPE. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Richards Medical Co., Inc. (Memphis, US). The FDA issued a Cleared decision on October 22, 1984 after a review of 39 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 Richards Medical Co., Inc. devices

FDA 510(k) Submission Details - K843604

510(k) Number K843604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1984
Decision Date October 22, 1984
Days to Decision 39 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
83d faster than avg
Panel avg: 122d · This submission: 39d
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 414
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K843604.
CO2 FOR ARTHROSCOPY
K852592 · The Anspach Effort, Inc. · Aug 1985
AMERICAN EDWARDS SMALL DIAMETER RIGID ENDOSCOPE
K851374 · American Edwards Laboratories · Jun 1985
CODMAN ARTHROSCOPE
K851229 · Codman & Shurtleff, Inc. · May 1985
ACUFEX ARTHROSCOPE
K843208 · Acufex Microsurgical, Inc. · Sep 1984
AMERICAN EDWARDS LABS FLEXISCOPE
K841607 · American Edwards Laboratories · Aug 1984
AMER. EDWARDS LAB FLEXISCOPE OBTURATOR
K842323 · American Edwards Laboratories · Aug 1984