GuideWire

Ear, Nose, And Throat Stereotaxic Instrument

FIAGON GMBH

The following data is part of a premarket notification filed by Fiagon Gmbh with the FDA for Guidewire.

Pre-market Notification Details

• Device ID: K160369
• 510k Number: K160369
• Device Name: GuideWire
• Classification: Ear, Nose, And Throat Stereotaxic Instrument
• Applicant: FIAGON GMBH NEUENDORFSTR. 23 B Hennigsdorf, DE 16761
• Contact: Dirk Mucha
• Correspondent: Dirk Mucha; FIAGON GMBH NEUENDORFSTR. 23 B Hennigsdorf, DE 16761
• Product Code: PGW
• CFR Regulation Number: 882.4560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-02-10
• Decision Date: 2016-03-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
EFIAE0129131	K160369	000