Cleared Traditional

K172978 - SurgeoBite

K172978 is an FDA 510(k) clearance for SurgeoBite, manufactured by Surgovations, LLC. The device is a Class 2 Neurology device with product code JXL cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K172978 · Surgovations, LLC · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2017
Decision
86d
Days
Class 2
Risk

K172978 is an FDA 510(k) clearance for the SurgeoBite. Classified as Block, Bite (product code JXL), Class II - Special Controls.

Submitted by Surgovations, LLC (Forsyth, US). The FDA issued a Cleared decision on December 22, 2017 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5070 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K172978

510(k) Number K172978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2017
Decision Date December 22, 2017
Days to Decision 86 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
63d faster than avg
Panel avg: 149d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JXL Device Classification - Class 2, Special Controls

Product Code JXL Block, Bite
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5070
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

Regulatory Resources Group, Inc.
Julie Stephens

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.

Regulatory Peers - JXL Block, Bite

All 18
Devices cleared under the same product code (JXL) and FDA review panel - the closest regulatory comparables to K172978.
PATI (Protector Against Tongue Injury)
K221469 · Neurovice, LLC · Feb 2023
ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium
K201309 · Mecta Corporation · Jun 2021
Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and Tongue Depressor 90 mm
K150518 · Dupaco, Inc. · Jun 2015
EPIGUARD
K050188 · Episafe Medical Devices, Ltd. · Apr 2005
VENTIL-A ORAL PROTECTOR
K992269 · Somatics, Inc. · Oct 1999
UNIVERSAL BITE BLOCK
K960663 · B&B Medical Technologies, Inc. · May 1996
K172978 · SurgeoBite
Download PDF FDA Summary Surgovations, LLC