CIRCON-SURGITEK CLASSIC DOUBLE PIGTAIL URETERAL STENT

Stent, Ureteral

CABOT MEDICAL CORP.

The following data is part of a premarket notification filed by Cabot Medical Corp. with the FDA for Circon-surgitek Classic Double Pigtail Ureteral Stent.

Pre-market Notification Details

• Device ID: K960148
• 510k Number: K960148
• Device Name: CIRCON-SURGITEK CLASSIC DOUBLE PIGTAIL URETERAL STENT
• Classification: Stent, Ureteral
• Applicant: CABOT MEDICAL CORP. 2021 CABOT BOULEVARD WEST Langhorne, PA 19047
• Contact: Todd J Polk
• Correspondent: Todd J Polk; CABOT MEDICAL CORP. 2021 CABOT BOULEVARD WEST Langhorne, PA 19047
• Product Code: FAD
• CFR Regulation Number: 876.4620 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-01-11
• Decision Date: 1996-03-25
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00821925002357	K960148	000
00821925004894	K960148	000
00821925004993	K960148	000
00821925005006	K960148	000
00821925005020	K960148	000
00821925005044	K960148	000
00821925005105	K960148	000
00821925005129	K960148	000
00821925005136	K960148	000
00821925005150	K960148	000
00821925005181	K960148	000
00821925005235	K960148	000
00821925005280	K960148	000
00821925004863	K960148	000
00821925004757	K960148	000
00821925002883	K960148	000
00821925003118	K960148	000
00821925003507	K960148	000
00821925003514	K960148	000
00821925003873	K960148	000
00821925003910	K960148	000
00821925004146	K960148	000
00821925004160	K960148	000
00821925004436	K960148	000
00821925004443	K960148	000
00821925004542	K960148	000
00821925004740	K960148	000
00821925005426	K960148	000
00821925005440	K960148	000
00821925005457	K960148	000
00821925006027	K960148	000
00821925006263	K960148	000
00821925006317	K960148	000
00821925006362	K960148	000
00821925006409	K960148	000
00821925006560	K960148	000
00821925006638	K960148	000
00821925006829	K960148	000
00821925006843	K960148	000
00821925006911	K960148	000
00821925007994	K960148	000
00821925008441	K960148	000
00821925006010	K960148	000
00821925005808	K960148	000
00821925005464	K960148	000
00821925005488	K960148	000
00821925005495	K960148	000
00821925005501	K960148	000
00821925005525	K960148	000
00821925005532	K960148	000
00821925005556	K960148	000
00821925005570	K960148	000
00821925005587	K960148	000
00821925005594	K960148	000
00821925005716	K960148	000
00821925005747	K960148	000
00821925031692	K960148	000