SURGITEK URINARY DIVERSION STENT

Stent, Ureteral

MEDICAL ENGINEERING CORP.

The following data is part of a premarket notification filed by Medical Engineering Corp. with the FDA for Surgitek Urinary Diversion Stent.

Pre-market Notification Details

• Device ID: K800109
• 510k Number: K800109
• Device Name: SURGITEK URINARY DIVERSION STENT
• Classification: Stent, Ureteral
• Applicant: MEDICAL ENGINEERING CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: FAD
• CFR Regulation Number: 876.4620 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1980-01-16
• Decision Date: 1980-02-26

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00821925006096	K800109	000
00821925006072	K800109	000