Urotronic Inc

FDA Filings

This page includes the latest FDA filings for Urotronic Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3015228875
• FEI Number: 3015228875
• Name: UROTRONIC INC
• Owner & Operator: Urotronic Inc
• Contact Address: 2495 Xenium Lane North ; Plymouth MN 55441 US
• Official Correspondent:
  • Brad Andersen
  • x-763-2857480-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2495 Xenium Lane North ; Plymouth, MN 55441 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 00853095008396 Urotronic, Inc.	Optilume Basic Urological Dilation catheter 1147-10050	2025-07-28
GUDID 00853095008389 Urotronic, Inc.	Optilume Basic Urological Dilation catheter 1147-10030	2025-07-28
GUDID 00853095008372 Urotronic, Inc.	Optilume Basic Urological Dilation catheter 1147-06050	2025-07-28
GUDID 00853095008365 Urotronic, Inc.	Optilume Basic Urological Dilation catheter 1147-06030	2025-07-28
GUDID 00853095008358 Urotronic, Inc.	Optilume Basic Urological Dilation catheter 1147-08050	2025-07-28
GUDID 00853095008341 Urotronic, Inc.	Optilume Basic Urological Dilation catheter 1147-08030	2025-07-28
GUDID 00853095008853 Urotronic, Inc.	Optilume BPH Catheter System 1189-30045	2023-08-14
GUDID 00853095008822 Urotronic, Inc.	Optilume BPH Catheter System 1189-30040	2023-08-14
GUDID 00853095008532 Urotronic, Inc.	Optilume BPH Drug Coated Balloon Catheter 1113-30045	2023-08-14
GUDID 00853095008426 Urotronic, Inc.	Optilume BPH Pre-dilation Catheter 1137-30030	2023-08-14
GUDID 00853095008402 Urotronic, Inc.	Optilume BPH Drug Coated Balloon Catheter 1113-30030	2023-08-14
GUDID 00853095008235 Urotronic, Inc.	Optilume BPH Catheter System 1189-30035	2023-08-14
GUDID 00853095008181 Urotronic, Inc.	Optilume BPH Catheter System 1189-30030	2023-08-14
GUDID 00853095008174 Urotronic, Inc.	Optilume BPH Drug Coated Balloon Catheter 1113-30040	2023-08-14
GUDID 00853095008150 Urotronic, Inc.	Optilume BPH Pre-dilation Catheter 1137-30035	2023-08-14
GUDID 00853095008129 Urotronic, Inc.	Optilume BPH Drug Coated Balloon Catheter 1113-30035	2023-08-14
GUDID 00853095008334 Urotronic, Inc.	Optilume Urethral Drug Coated Balloon 1110-06050B	2022-12-12
GUDID 00853095008327 Urotronic, Inc.	Optilume Urethral Drug Coated Balloon 1110-08030B	2022-12-12
GUDID 00853095008310 Urotronic, Inc.	Optilume Urethral Drug Coated Balloon 1110-10050B	2022-12-12
GUDID 00853095008303 Urotronic, Inc.	Optilume Urethral Drug Coated Balloon 1110-08050B	2022-12-12
GUDID 00853095008297 Urotronic, Inc.	Optilume Urethral Drug Coated Balloon 1110-10030B	2022-12-12
GUDID 00853095008280 Urotronic, Inc.	Optilume Urethral Drug Coated Balloon 1110-06030B	2022-12-12
GUDID 00853095008273 Urotronic, Inc.	Optilume Urethral Drug Coated Balloon 1110-12050B	2022-12-12
GUDID 00853095008242 Urotronic, Inc.	Optilume Urethral Drug Coated Balloon 1110-12030B	2022-12-12
PMA P210020S003 Urotronic, Inc.	Optilume Urethral Drug Coated Balloon	2022-02-03
PMA P210020S002 Urotronic, Inc.	Optilume Urethral Drug Coated Balloon	2022-01-27
PMA P210020S001 Urotronic, Inc.	Optilume Urethral Drug Coated Balloon	2022-01-19
PMA P210020 Urotronic, Inc.	Optilume Urethral Drug Coated Balloon	2021-12-03
PMN K191061 | KOE UROTRONIC INC	Optilume Basic Urological Balloon Dilation Catheter	2020-03-16
PMN K191061 Urotronic Inc	Optilume Basic Urological Balloon Dilation Catheter	2020-01-02

Similar & Related FDA Registered Companies

• Urotronic, Inc.2495 Xenium Laneminneapolis, MN 55441 PMA NumberP210020 Supplement NumberS006 Date Received08/30/2022 Decision Date09/29/2022 Product Code QRH  Advisory Committee Gastroenterology/Urology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
• Urotronic, Inc.2495 Xenium Laneminneapolis, MN 55441 PMA NumberP210020 Supplement NumberS005 Date Received05/12/2022 Decision Date06/10/2022 Product Code QRH  Advisory Committee Gastroenterology/Urology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
• Urotronic, Inc.2495 Xenium Laneminneapolis, MN 55441 PMA NumberP210020 Supplement NumberS004 Date Received02/24/2022 Decision Date05/17/2022 Product Code QRH  Advisory Committee Gastroenterology/Urology Supplement Typereal-time Process Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

Related Finance Registrations

NCAGE Code	7TDJ9	UROTRONIC, INC.
CAGE Code	7TDJ9	UROTRONIC, INC.
DUNS	080558603	Urotronic, Inc.
SEC	0001745565	Urotronic, Inc. of DELAWARE