Advanced Surgical Concepts L T D

FDA Filings

This page includes the latest FDA filings for Advanced Surgical Concepts L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 9616720
• FEI Number: 3003283598
• Name: ADVANCED SURGICAL CONCEPTS (ASC)
• Owner & Operator: Advanced Surgical Concepts Limited
• Contact Address: Sunnybank Centre Upper Dargle Road; Bray IE-WW Wicklow -- IE
• US Agent:
  • Troy C Quander
  • Vice President Regulatory Affairs
  • 508 8044716
  • 508 8042624
  • troy.quander@olympus-osta.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: UNIT 4, SUNNYBANK CENTRE ; BRAY Wicklow, -- IE
• Establishment Type:
  • Develop Specifications But Do Not Manufacture At This Facility
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 05391530440134 ADVANCED SURGICAL CONCEPTS LIMITED	Guardenia	2021-12-17
PMN K211234 Advanced Surgical Concepts Ltd	RedEx	2021-09-17
GUDID 05391530440103 ADVANCED SURGICAL CONCEPTS LIMITED	QuadPort+	2018-07-06
GUDID 05391530440097 ADVANCED SURGICAL CONCEPTS LIMITED	TriPort15	2018-07-06
GUDID 05391530440066 ADVANCED SURGICAL CONCEPTS LIMITED	TriPort+	2018-07-06
GUDID 05391530440011 ADVANCED SURGICAL CONCEPTS LIMITED	PneumoLiner	2018-07-06
De Novo DEN170075 Advanced Surgical Concepts Ltd.	ContainOR	2017-12-19
PMN DEN150028 | PMU ADVANCED SURGICAL CONCEPTS (ASC) [Advanced Surgical Concepts Limited]	PneumoLiner	2016-09-16
De Novo DEN150028 ADVANCED SURGICAL CONCEPTS LTD.	PneumoLiner	2016-04-07
PMN K121309 | OTJ ADVANCED SURGICAL CONCEPTS (ASC) [Advanced Surgical Concepts Limited]	QuadPort+	2012-11-21
PMN K111407 | OTJ ADVANCED SURGICAL CONCEPTS (ASC) [Advanced Surgical Concepts Limited]	TriPort 15	2012-11-21
PMN K110004 | OTJ ADVANCED SURGICAL CONCEPTS (ASC) [Advanced Surgical Concepts Limited]	TriPort +	2012-11-21
PMN K110004 | GCJ ADVANCED SURGICAL CONCEPTS (ASC) [Advanced Surgical Concepts Limited]	TriPort +	2012-11-21
PMN K101794 | OTJ ADVANCED SURGICAL CONCEPTS (ASC) [Advanced Surgical Concepts Limited]	TriPort	2012-11-21
PMN K101794 | OTJ ADVANCED SURGICAL CONCEPTS (ASC) [Advanced Surgical Concepts Limited]	QuadPort	2012-11-21
PMN K101794 | GCJ ADVANCED SURGICAL CONCEPTS (ASC) [Advanced Surgical Concepts Limited]	TriPort	2012-11-21
PMN K101794 | GCJ ADVANCED SURGICAL CONCEPTS (ASC) [Advanced Surgical Concepts Limited]	QuadPort	2012-11-21
PMN K073719 | GCJ ADVANCED SURGICAL CONCEPTS (ASC) [Advanced Surgical Concepts Limited]	TriPort	2009-10-05