Cleared Traditional

2.3 MM DISPOSABLE NEUROVIEW ENDOSCOPE (K940483) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K940483 · Neuro Navigational Corp. · Orthopedic device
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May 1995
Decision
454d
Days
Class 2
Risk

K940483 is an FDA 510(k) clearance for the 2.3 MM DISPOSABLE NEUROVIEW ENDOSCOPE. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Neuro Navigational Corp. (Costa Mesa, US). The FDA issued a Cleared decision on May 2, 1995 after a review of 454 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Neuro Navigational Corp. devices

Submission Details

510(k) Number K940483 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received February 02, 1994
Decision Date May 02, 1995
Days to Decision 454 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
332d slower than avg
Panel avg: 122d · This submission: 454d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 178
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K940483.
ARTHROSCOPE FOR SMALL JOINT AFTER FELDKAMP, MODEL 8871.011
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K950561 · KARL STORZ Endoscopy-America, Inc. · May 1995
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K946151 · Depuy, Inc. · May 1995
THE KARL STORZ ARTHROPUMP
K942298 · KARL STORZ Endoscopy-America, Inc. · Jan 1995
TRANSTIBIAL ACL DISPOSABLES KIT
K943943 · Arthrex, Inc. · Dec 1994
KARL STORTZ OBTURATOR)SHARP/BLUNT)/CANNULAE/SHEATHS
K943154 · KARL STORZ Endoscopy-America, Inc. · Dec 1994