Cleared Traditional

K991656 - AED ARTHROSCOPE

K991656 is an FDA 510(k) clearance for AED ARTHROSCOPE, manufactured by National Advanced Endoscopy Devices, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K991656 · National Advanced Endoscopy Devices, Inc. · Orthopedic device
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Dec 1999
Decision
203d
Days
Class 2
Risk

K991656 is an FDA 510(k) clearance for the AED ARTHROSCOPE. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by National Advanced Endoscopy Devices, Inc. (Los Angeles, US). The FDA issued a Cleared decision on December 2, 1999 after a review of 203 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.

View all National Advanced Endoscopy Devices, Inc. devices

FDA 510(k) Submission Details - K991656

510(k) Number K991656 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1999
Decision Date December 02, 1999
Days to Decision 203 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 122d · This submission: 203d
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 452
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K991656.
INSTRUMENTS FOR MINIMALLY INVASIVE SPINAL SURGERY (MISS)
K994363 · Richard Wolf Medical Instruments Corp. · Mar 2000
MODIFICATION TO ENDOSCOPIC SPINAL ACCESS SYSTEM
K994425 · Endius, Inc. · Feb 2000
ARTHRO-SURGIMAT-A103
K000153 · W.O.M. World of Medicine GmbH · Feb 2000
ENDOSPINE OPERATING TUBE AND TELESCOPE BRIDGE
K993540 · KARL STORZ Endoscopy-America, Inc. · Nov 1999
METRX SYSTEM
K993021 · Surgical Navigation Technologies, Inc. · Nov 1999
FLEXIBLE FIBERSCOPES & ACCESSORIES
K990397 · Richard Wolf Medical Instruments Corp. · Oct 1999