Cleared Traditional

K880295 - CANNULA MODEL AR-6001

K880295 is an FDA 510(k) clearance for CANNULA MODEL AR-6001, manufactured by Arthrex Arthroscopy Instruments, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K880295 · Arthrex Arthroscopy Instruments, Inc. · Orthopedic device
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Jun 1988
Decision
156d
Days
Class 2
Risk

K880295 is an FDA 510(k) clearance for the CANNULA MODEL AR-6001. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Arthrex Arthroscopy Instruments, Inc. (Norwalk, US). The FDA issued a Cleared decision on June 29, 1988 after a review of 156 days - an extended review 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: 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.

FDA 510(k) Submission Details - K880295

510(k) Number K880295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1988
Decision Date June 29, 1988
Days to Decision 156 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 122d · This submission: 156d
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 665
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K880295.
EDWARDS ARTHROSCOPIC LEG HOLDER
K884302 · Baxter Healthcare Corp · Nov 1988
28200 SERIES MICRO-ARTHRO. STERILE DISP. BLADES
K881715 · KARL STORZ Endoscopy-America, Inc. · Aug 1988
3M CARPAL TUNNEL
K881703 · 3M Company · Jul 1988
HERMAN CANNULA SET
K880203 · Orthopedic Systems, Inc. · Apr 1988
TENDON HARVESTER
K880414 · Concept, Inc. · Mar 1988
MCCAIN INSTRUMENT TMJ/SM. JOINT ARTHROSCOPIC SURG
K874911 · Walter Lorenz Surgical, Inc. · Feb 1988
K880295 · CANNULA MODEL AR-6001
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