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)
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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.

View all Surgovations, LLC devices

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
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 148d · 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 Peers - JXL Block, Bite

All 11
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
UNIVERSAL BITE BLOCK
K960663 · B&B Medical Technologies, Inc. · May 1996
BITE BLOCK
K954352 · United States Endoscopy Group, Inc. · Jan 1996
PREMIER PROMAX BITE GUARD
K941856 · Premier Dental Products Co. · Apr 1995
BITE BLOCK
K924304 · United States Endoscopy Group, Inc. · Apr 1993