Cleared Traditional

cCeLL - In vivo

K233391 · VPIX Medical, Inc. · Neurology

Aug 2024

Decision

324d

Days

Class 2

Risk

About This 510(k) Submission

K233391 is an FDA 510(k) clearance for the cCeLL - In vivo, a Endoscope, Neurological (Class II — Special Controls, product code GWG), submitted by VPIX Medical, Inc. (Daejeon, KR). The FDA issued a Cleared decision on August 21, 2024, 324 days after receiving the submission on October 2, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1480.

Submission Details

510(k) Number	K233391 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 02, 2023
Decision Date	August 21, 2024
Days to Decision	324 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	GWG — Endoscope, Neurological
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.1480
Definition	If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).