URETERAL STENT

Stent, Ureteral

SURGITEK

The following data is part of a premarket notification filed by Surgitek with the FDA for Ureteral Stent.

Pre-market Notification Details

• Device ID: K930733
• 510k Number: K930733
• Device Name: URETERAL STENT
• Classification: Stent, Ureteral
• Applicant: SURGITEK 3037 MT. PLEASANT ST. Racine, WI 53404
• Contact: Brian Kunst
• Correspondent: Brian Kunst; SURGITEK 3037 MT. PLEASANT ST. Racine, WI 53404
• Product Code: FAD
• CFR Regulation Number: 876.4620 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-02-11
• Decision Date: 1993-07-23

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00821925001091	K930733	000
00821925006874	K930733	000
00821925006928	K930733	000
00821925006973	K930733	000
00821925006980	K930733	000
00821925006997	K930733	000
00821925007093	K930733	000
00821925007161	K930733	000
00821925007178	K930733	000
00821925007185	K930733	000
00821925007208	K930733	000
00821925007215	K930733	000
00821925007239	K930733	000
00821925007277	K930733	000
00821925007987	K930733	000
00821925006867	K930733	000
00821925006799	K930733	000
00821925001107	K930733	000
00821925001350	K930733	000
00821925001404	K930733	000
00821925002142	K930733	000
00821925004979	K930733	000
00821925005198	K930733	000
00821925005228	K930733	000
00821925005631	K930733	000
00821925006157	K930733	000
00821925006270	K930733	000
00821925006652	K930733	000
00821925006768	K930733	000
00821925006775	K930733	000
00821925006782	K930733	000
00821925031524	K930733	000
00821925031531	K930733	000
00821925031715	K930733	000
00821925031722	K930733	000
00821925031739	K930733	000
00821925031746	K930733	000
00821925031753	K930733	000
00821925031760	K930733	000
00821925031777	K930733	000
00821925031784	K930733	000
00821925031791	K930733	000
00821925031807	K930733	000
00821925031814	K930733	000
00821925031821	K930733	000
00821925031838	K930733	000
00821925031845	K930733	000
00821925031708	K930733	000
00821925031685	K930733	000
00821925031548	K930733	000
00821925031555	K930733	000
00821925031562	K930733	000
00821925031579	K930733	000
00821925031586	K930733	000
00821925031593	K930733	000
00821925031609	K930733	000
00821925031616	K930733	000
00821925031623	K930733	000
00821925031630	K930733	000
00821925031647	K930733	000
00821925031654	K930733	000
00821925031661	K930733	000
00821925031678	K930733	000
00821925031852	K930733	000