Cleared Traditional

K002764 - HYDROCISION ARTHROJET SYSTEM WITH CAUTE...

K002764 is an FDA 510(k) clearance for HYDROCISION ARTHROJET SYSTEM WITH CAUTE..., manufactured by Hydrocision, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K002764 · Hydrocision, Inc. · Orthopedic device
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Nov 2000
Decision
80d
Days
Class 2
Risk

K002764 is an FDA 510(k) clearance for the HYDROCISION ARTHROJET SYSTEM WITH CAUTERY AND BURR. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Hydrocision, Inc. (Hopkonton, US). The FDA issued a Cleared decision on November 24, 2000 after a review of 80 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 Hydrocision, Inc. devices

FDA 510(k) Submission Details - K002764

510(k) Number K002764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2000
Decision Date November 24, 2000
Days to Decision 80 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 122d · This submission: 80d
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 K002764.
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METRX SYSTEM
K002931 · Medtronic Sofamor Danek, Inc. · Nov 2000
RADIONICS RF DISC CATHETER ELECTRODE SYSTEM
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ENDIUS ENDOSCOPIC ACCESS SYSTEM
K002437 · Endius, Inc. · Oct 2000