Cleared Traditional

K834146 - ANTHROSCOPY SYSTEM

K834146 is an FDA 510(k) clearance for ANTHROSCOPY SYSTEM, manufactured by Cabot Medical Corp.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K834146 · Cabot Medical Corp. · Orthopedic device
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Mar 1984
Decision
98d
Days
Class 2
Risk

K834146 is an FDA 510(k) clearance for the ANTHROSCOPY SYSTEM. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Cabot Medical Corp. (Mchenry, US). The FDA issued a Cleared decision on March 8, 1984 after a review of 98 days - within the typical 510(k) review window.

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 Cabot Medical Corp. devices

FDA 510(k) Submission Details - K834146

510(k) Number K834146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1983
Decision Date March 08, 1984
Days to Decision 98 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
24d faster than avg
Panel avg: 122d · This submission: 98d
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 415
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K834146.
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
CABOT ARTHROSCOPY SYSTEM
K833727 · Cabot Medical Corp. · Dec 1983
ARTHROSCOPY FLUID MGMT. SYSTEM
K832315 · 3M Health Care, Sarns · Oct 1983
ACUFLEX LEVY ACL DRILL GUIDE SYS
K832277 · Acufex Microsurgical, Inc. · Aug 1983