Cleared Special

K191594 - Nuvis Battery Arthroscope (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K191594 · Integrated Endoscopy, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2019
Decision
24d
Days
Class 2
Risk

K191594 is an FDA 510(k) clearance for the Nuvis Battery Arthroscope. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Integrated Endoscopy, Inc. (Irvine, US). The FDA issued a Cleared decision on July 11, 2019 after a review of 24 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 888.1100 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Integrated Endoscopy, Inc. devices

Submission Details

510(k) Number K191594 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2019
Decision Date July 11, 2019
Days to Decision 24 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 114d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - HRX Arthroscope

All 679
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