NeuGuide

Fixation, Non-absorbable Or Absorbable, For Pelvic Use

POP Medical Solutions

The following data is part of a premarket notification filed by Pop Medical Solutions with the FDA for Neuguide.

Pre-market Notification Details

• Device ID: K160569
• 510k Number: K160569
• Device Name: NeuGuide
• Classification: Fixation, Non-absorbable Or Absorbable, For Pelvic Use
• Applicant: POP Medical Solutions 27 Habarzel ST. Tel Aviv, IL 6971039
• Contact: Guy Ohad
• Correspondent: Paul Dryden; POP Medical Solutions 27 Habarzel ST. Tel Aviv, IL 6971039
• Product Code: PBQ
• CFR Regulation Number: 884.4530 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-02-29
• Decision Date: 2016-07-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07290017082004	K160569	000
17290017082025	K160569	000