Cleared Traditional

K180270 - Cellvizio 100 Series Systems with Confo...

K180270 is an FDA 510(k) clearance for Cellvizio 100 Series Systems with Confo..., manufactured by Mauna Kea Technologies. The device is a Class 2 Neurology device with product code GWG cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K180270 · Mauna Kea Technologies · Neurology device
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May 2018
Decision
111d
Days
Class 2
Risk

K180270 is an FDA 510(k) clearance for the Cellvizio 100 Series Systems with Confocal Miniprobes. Classified as Endoscope, Neurological (product code GWG), Class II - Special Controls.

Submitted by Mauna Kea Technologies (Paris, FR). The FDA issued a Cleared decision on May 22, 2018 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1480 - the FDA neurology device 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Mauna Kea Technologies devices

FDA 510(k) Submission Details - K180270

510(k) Number K180270 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2018
Decision Date May 22, 2018
Days to Decision 111 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 148d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWG Device Classification - Class 2, Special Controls

Product Code GWG Endoscope, Neurological
Device Class Class 2 - 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).
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 Neurology devices follow this clearance model.

Regulatory Consultant

Daniel & Daniel Consulting
Michael A. Daniel

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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All 78
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