TGS Universal Headrest With Mounting Arm

Ear, Nose, And Throat Stereotaxic Instrument

Stryker ENT

The following data is part of a premarket notification filed by Stryker Ent with the FDA for Tgs Universal Headrest With Mounting Arm.

Pre-market Notification Details

• Device ID: K193502
• 510k Number: K193502
• Device Name: TGS Universal Headrest With Mounting Arm
• Classification: Ear, Nose, And Throat Stereotaxic Instrument
• Applicant: Stryker ENT 3600 Holly Lane North, Suite 40 Plymouth, MN 55447
• Contact: Denise Thompson
• Correspondent: Denise Thompson; Stryker ENT 3600 Holly Lane North, Suite 40 Plymouth, MN 55447
• Product Code: PGW
• CFR Regulation Number: 882.4560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-12-18
• Decision Date: 2020-02-14

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00850002250275	K193502	000
00850002250268	K193502	000
00850002250251	K193502	000
00850002250244	K193502	000
00850002250237	K193502	000