Esophageal TTS Stent

Prosthesis, Esophageal

Taewoong Medical Co., Ltd.

The following data is part of a premarket notification filed by Taewoong Medical Co., Ltd. with the FDA for Esophageal Tts Stent.

Pre-market Notification Details

• Device ID: K221482
• 510k Number: K221482
• Device Name: Esophageal TTS Stent
• Classification: Prosthesis, Esophageal
• Applicant: Taewoong Medical Co., Ltd. 14 Gojeong-Ro, Wolgot-Myeon Gimpo-Si, KR 10022
• Contact: Jangsoo Lee
• Correspondent: Matthew Krueger; Biologics Consulting Group, Inc. 1555 King Street, Suite 300 Alexandria, VA 22314
• Product Code: ESW
• CFR Regulation Number: 878.3610 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2022-05-23
• Decision Date: 2022-06-22

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08809744975481	K221482	000
08809744975672	K221482	000
08809744975689	K221482	000
08809744975696	K221482	000
08809744975702	K221482	000
08809744975719	K221482	000
08809744975726	K221482	000
08809744975733	K221482	000
08809744975740	K221482	000
08809744975757	K221482	000
08809744975764	K221482	000
08809744975771	K221482	000
08809744975788	K221482	000
08809744975795	K221482	000
08809744975801	K221482	000
08809744975818	K221482	000
08809744975825	K221482	000
08809744975665	K221482	000
08809744975658	K221482	000
08809744975498	K221482	000
08809744975504	K221482	000
08809744975511	K221482	000
08809744975528	K221482	000
08809744975535	K221482	000
08809744975542	K221482	000
08809744975559	K221482	000
08809744975566	K221482	000
08809744975573	K221482	000
08809744975580	K221482	000
08809744975597	K221482	000
08809744975603	K221482	000
08809744975610	K221482	000
08809744975627	K221482	000
08809744975634	K221482	000
08809744975641	K221482	000
08809744975832	K221482	000
08809744975849	K221482	000
08809744976037	K221482	000
08809744976044	K221482	000
08809744976051	K221482	000
08809744976068	K221482	000
08809744976075	K221482	000
08809744976082	K221482	000
08809744976099	K221482	000
08809744976105	K221482	000
08809744976112	K221482	000
08809744976129	K221482	000
08809744976136	K221482	000
08809744976143	K221482	000
08809744976150	K221482	000
08809744976167	K221482	000
08809744976174	K221482	000
08809744976181	K221482	000
08809744976020	K221482	000
08809744976013	K221482	000
08809744975856	K221482	000
08809744975863	K221482	000
08809744975870	K221482	000
08809744975887	K221482	000
08809744975894	K221482	000
08809744975900	K221482	000
08809744975917	K221482	000
08809744975924	K221482	000
08809744975931	K221482	000
08809744975948	K221482	000
08809744975955	K221482	000
08809744975962	K221482	000
08809744975979	K221482	000
08809744975986	K221482	000
08809744975993	K221482	000
08809744976006	K221482	000
08809744976198	K221482	000