Cleared Special

K212355 - Checkpoint Guardian Intraoperative Lead

K212355 is an FDA 510(k) clearance for Checkpoint Guardian Intraoperative Lead, manufactured by Checkpoint Surgical. The device is a Class 2 Ear, Nose, Throat device with product code ETN cleared through the Special 510(k) pathway after a 28-day FDA review.

K212355 · Checkpoint Surgical · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2021
Decision
28d
Days
Class 2
Risk

K212355 is an FDA 510(k) clearance for the Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraope.... Classified as Stimulator, Nerve (product code ETN), Class II - Special Controls.

Submitted by Checkpoint Surgical (Independence, US). The FDA issued a Cleared decision on August 26, 2021 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.1820 - the FDA ear, nose and throat 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 Checkpoint Surgical devices

FDA 510(k) Submission Details - K212355

510(k) Number K212355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2021
Decision Date August 26, 2021
Days to Decision 28 days
Submission Type Special
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 89d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

ETN Device Classification - Class 2, Special Controls

Product Code ETN Stimulator, Nerve
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1820
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 Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - ETN Stimulator, Nerve

All 42
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