Cleared Special

K232787 - ScanNav Anatomy Peripheral Nerve Block (FDA 510(k) Clearance)

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

K232787 · Intelligent Ultrasound Limited · Anesthesiology device
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Oct 2023
Decision
25d
Days
Class 2
Risk

K232787 is an FDA 510(k) clearance for the ScanNav Anatomy Peripheral Nerve Block. Classified as Ultrasound Guided Nerve Block Assist (product code QRG), Class II - Special Controls.

Submitted by Intelligent Ultrasound Limited (Cardiff, GB). The FDA issued a Cleared decision on October 6, 2023 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1980 - the FDA anesthesiology and respiratory 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 Intelligent Ultrasound Limited devices

Submission Details

510(k) Number K232787 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2023
Decision Date October 06, 2023
Days to Decision 25 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
114d faster than avg
Panel avg: 139d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code QRG Ultrasound Guided Nerve Block Assist
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1980
Definition This Device Provides Real-time Interpretation And Enhanced Visualization Of Live Ultrasound Images By Highlighting Anatomical Landmarks In Preparation For Performing Regional Anesthesia.
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 Anesthesiology devices follow this clearance model.