The following data is part of a premarket notification filed by Advanced Surgical Concepts (asc) with the FDA for Omniport.
| Device ID | K002013 | 
| 510k Number | K002013 | 
| Device Name: | OMNIPORT | 
| Classification | Laparoscope, General & Plastic Surgery | 
| Applicant | ADVANCED SURGICAL CONCEPTS (ASC) 49 PLAIN ST. North Attleboro, MA 02760 | 
| Contact | Mary Mcnamara-cullinane | 
| Correspondent | Mary Mcnamara-cullinane ADVANCED SURGICAL CONCEPTS (ASC) 49 PLAIN ST. North Attleboro, MA 02760  | 
| Product Code | GCJ | 
| CFR Regulation Number | 876.1500 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 2000-07-03 | 
| Decision Date | 2000-09-29 | 
Mark Image Registration | Serial  | Company  Trademark Application Date  | 
|---|---|
![]() OMNIPORT  78875954  3211390 Live/Registered  | 
        E+E Elektronik Ges.m.b.H.  2006-05-03  | 
![]() OMNIPORT  78040144  not registered Dead/Abandoned  | 
        Lexicon Media Communications, inc.  2000-12-20  | 
![]() OMNIPORT  77254736  not registered Dead/Abandoned  | 
        Cellport Systems, Inc.  2007-08-14  | 
![]() OMNIPORT  76220609  2875969 Dead/Cancelled  | 
        Advanced Surgical Concepts Limited  2001-03-05  | 
![]() OMNIPORT  75665109  not registered Dead/Abandoned  | 
        RCM Technologies, Inc.  1999-03-22  | 
![]() OMNIPORT  75141209  not registered Dead/Abandoned  | 
        BDSI, Inc.  1996-07-29  | 
![]() OMNIPORT  75141208  not registered Dead/Abandoned  | 
        BDSI, Inc.  1996-07-29  | 
![]() OMNIPORT  75105631  not registered Dead/Abandoned  | 
        CellPort Labs, Inc.  1996-05-17  | 
![]() OMNIPORT  74402047  not registered Dead/Abandoned  | 
        AT&T CORP.  1993-06-11  | 
![]() OMNIPORT  73743642  1540912 Dead/Cancelled  | 
        CMT SYSTEMS  1988-08-01  |