Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control …

FDA 510(k)

Class II (US FDA 510(k))

510(k) K201840

Identifiers

510(k) Number: K201840 FDA 510(k)
FDA Product Code: GWG FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 882.1480 FDA 510(k)
Regulation Number: 882.1480 FDA 510(k)
Advisory Committee: Neurology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control … by Rebound Therapeutics Corporation — Class II — FDA_510K — listed in FDA…

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K201840	Class II	Active

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Manufacturer

Manufacturer: Rebound Therapeutics Corporation
FDA Applicant: Rebound Therapeutics

Sources (1)

FDA 510(k) K201840 24 fields · synced Jun 18, 2026