FDA.reportPublic FDA data

510(k) K221469

Device
PATI (Protector Against Tongue Injury)
Applicant
Neurovice, LLC
510(k) number
K221469
Product code
JXL
Decision
Substantially Equivalent (SESE)
Decision date
2023-02-22
Date received
2022-05-20
Regulation
882.5070
Classification name
Block, Bite
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Ashlyn Sanders
Address
7928 Woodcross Way Wake Forest NC US 27587 27587

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JXL#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K201309ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size MediumMecta Corporation2021-06-04
K172978SurgeoBiteSurgovations, LLC2017-12-22
K150518Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and Tongue Depressor 90 mmDupaco, Inc.2015-06-29
K050188EPIGUARDEpisafe Medical Devices, Ltd.2005-04-27
K992269VENTIL-A ORAL PROTECTORSomatics, Inc.1999-10-25
K960663UNIVERSAL BITE BLOCKB&B Medical Technologies, Inc.1996-05-17
K954352BITE BLOCKUnited States Endoscopy Group, Inc.1996-01-25
K941856PREMIER PROMAX BITE GUARDPremier Dental Products Co.1995-04-05
K924333THE DAVIS DISPOSABLE PROTECTIVE SPLINTOra-Gard, Inc.1993-04-23
K924304BITE BLOCKUnited States Endoscopy Group, Inc.1993-04-06
K921946TUM-E-VAC BITE BLOCKEthox Corp.1992-12-09
K901563MOUTHPIECE BREATHINGScott All-Sports, Inc.1990-06-28
K896745JAW BLOCKERPlastic Engineered Products Co.1989-12-14
K890567BITE BLOCK #59430Medi-Source, Inc.1989-02-17
K883416MOUTHPIECE BREATHING (PERFORMANCE MOUTHGUARD)Scott All-Sports, Inc.1988-10-12