The following data is part of a premarket notification filed by Advanced Surgical Concepts Ltd with the FDA for Redex.
| Device ID | K211234 | 
| 510k Number | K211234 | 
| Device Name: | RedEx | 
| Classification | Laparoscope, General & Plastic Surgery | 
| Applicant | Advanced Surgical Concepts Ltd Unit 4, Sunnybank Center, Upper Dargle Road Bray, IE A98 E339 | 
| Contact | Edward Hyland | 
| Correspondent | Jonathan S. Kahan Hogan Lovells US LLP Columbia Square, 555 Thirteenth Street, NW Washington, DC 20004  | 
| Product Code | GCJ | 
| CFR Regulation Number | 876.1500 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 2021-04-23 | 
| Decision Date | 2021-09-17 | 
| Device Identifier | submissionNumber | Supplement | 
|---|---|---|
| 05391530440134 | K211234 | 000 | 
Mark Image Registration | Serial  | Company  Trademark Application Date  | 
|---|---|
![]() REDEX  98097404  not registered Live/Pending  | 
        Chongqing Jianchenghe Hardware BuildingMaterials Co., Ltd  2023-07-22  | 
![]() REDEX  79159980  4853300 Live/Registered  | 
        Diringer & Scheidel Rohrsanierung GmbH &Co. KG  2014-07-24  | 
![]() REDEX  79151310  4783877 Live/Registered  | 
        Rico-Sicherheitstechnik AG  2014-06-24  | 
![]() REDEX  79084495  4140660 Live/Registered  | 
        REDEX  2010-06-17  | 
![]() REDEX  78969618  3722425 Dead/Cancelled  | 
        Redex Limited  2006-09-07  | 
![]() REDEX  77249535  not registered Dead/Abandoned  | 
        akaRED LLC  2007-08-07  | 
![]() REDEX  76383884  3038780 Dead/Cancelled  | 
        CORELOGIC CASE-SHILLER, LLC  2002-03-18  | 
![]() REDEX  74534796  1900653 Dead/Cancelled  | 
        Louisiana-Pacific Corporation  1994-06-08  | 
![]() REDEX  74525832  2063640 Dead/Cancelled  | 
        MODERN TECHNOLOGIES CORP.  1994-05-17  | 
![]() REDEX  74083222  1651850 Dead/Cancelled  | 
        Redex Packaging Corp.  1990-07-30  | 
![]() REDEX  73513502  1365933 Dead/Cancelled  | 
        FIREDEX, INC.  1984-12-13  | 
![]() REDEX  73490043  1364865 Dead/Cancelled  | 
        REDEX, INC.  1984-07-16  |