Cleared Traditional

K082355 - VISIONSENSE STEREOSCOPIC VISION SYSTEM

K082355 is an FDA 510(k) clearance for VISIONSENSE STEREOSCOPIC VISION SYSTEM, manufactured by Visionsense, Ltd.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K082355 · Visionsense, Ltd. · Orthopedic device
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Dec 2008
Decision
122d
Days
Class 2
Risk

K082355 is an FDA 510(k) clearance for the VISIONSENSE STEREOSCOPIC VISION SYSTEM. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Visionsense, Ltd. (Washington, US). The FDA issued a Cleared decision on December 15, 2008 after a review of 122 days - within the typical 510(k) review window.

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 Visionsense, Ltd. devices

FDA 510(k) Submission Details - K082355

510(k) Number K082355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2008
Decision Date December 15, 2008
Days to Decision 122 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 122d · This submission: 122d
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 567
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