SURGITEK DOUBLE J URETEROL 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 Double J Ureterol Stent.

Pre-market Notification Details

• Device ID: K781641
• 510k Number: K781641
• Device Name: SURGITEK DOUBLE J URETEROL 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: 1978-09-21
• Decision Date: 1978-12-07

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00821925007154	K781641	000
00821925006386	K781641	000
00821925006218	K781641	000
00821925006201	K781641	000
00821925006195	K781641	000
00821925006188	K781641	000
00821925006171	K781641	000
00821925006164	K781641	000
00821925006140	K781641	000
00821925005839	K781641	000
00821925005822	K781641	000
00821925005709	K781641	000
00821925005334	K781641	000
00821925005211	K781641	000
00821925005099	K781641	000
00821925006393	K781641	000
00821925006416	K781641	000
00821925006423	K781641	000
00821925006584	K781641	000
00821925006553	K781641	000
00821925006546	K781641	000
00821925006539	K781641	000
00821925006522	K781641	000
00821925006515	K781641	000
00821925006508	K781641	000
00821925006492	K781641	000
00821925006485	K781641	000
00821925006478	K781641	000
00821925006461	K781641	000
00821925006454	K781641	000
00821925006447	K781641	000
00821925006430	K781641	000
00821925001879	K781641	000