Cleared Special

K020688 - HYDROCISION ARTHOJET SYSTEM WITH CAUTER...

K020688 is an FDA 510(k) clearance for HYDROCISION ARTHOJET SYSTEM WITH CAUTER..., manufactured by Hydrocision, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Special 510(k) pathway after a 30-day FDA review.

K020688 · Hydrocision, Inc. · Orthopedic device
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Apr 2002
Decision
30d
Days
Class 2
Risk

K020688 is an FDA 510(k) clearance for the HYDROCISION ARTHOJET SYSTEM WITH CAUTERY AND TURBOBURR. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Hydrocision, Inc. (Hopkonton, US). The FDA issued a Cleared decision on April 3, 2002 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Hydrocision, Inc. devices

FDA 510(k) Submission Details - K020688

510(k) Number K020688 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2002
Decision Date April 03, 2002
Days to Decision 30 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 K020688.
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POWER TEK II
K020761 · Biomet, Inc. · Apr 2002
RESECTION ABLATOR
K013117 · Linvatec Corp. · Nov 2001
REPROCESSED DYONICS ARTHROSCOPIC BURS
K012652 · Alliance Medical Corp. · Nov 2001