PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor
Esophagoscope (flexible Or Rigid)
Cogentix Medical, Inc.
The following data is part of a premarket notification filed by Cogentix Medical, Inc. with the FDA for Primesight™ Unity 9000 Video Processor, Primesight™ Unity 9100 Video Processor.
Pre-market Notification Details
| Device ID | K181292 |
| 510k Number | K181292 |
| Device Name: | PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor |
| Classification | Esophagoscope (flexible Or Rigid) |
| Applicant | Cogentix Medical, Inc. 40 Ramland Road South Orangeburg, NY 10962 |
| Contact | Christa Blaisdell |
| Correspondent | Christa Blaisdell Cogentix Medical, Inc. 40 Ramland Road South Orangeburg, NY 10962 |
| Product Code | EOX |
| Subsequent Product Code | EOB |
| Subsequent Product Code | EOQ |
| Subsequent Product Code | FAJ |
| Subsequent Product Code | OCS |
| CFR Regulation Number | 874.4710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-16 |
| Decision Date | 2018-11-15 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00874485003227 | K181292 | 000 |
| 00874485003210 | K181292 | 000 |
Trademark Results [PrimeSight]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PRIMESIGHT 98190784 not registered Live/Pending |
Physician Equity Holdings, LLC 2023-09-21 |
 PRIMESIGHT 87804045 not registered Dead/Abandoned |
Cogentix Medical, Inc. 2018-02-20 |
 PRIMESIGHT 87804033 5877165 Live/Registered |
Cogentix Medical, Inc. 2018-02-20 |
 PRIMESIGHT 75277490 2274821 Dead/Cancelled |
PrimeSight 1997-04-18 |
 PRIMESIGHT 75277433 2206201 Dead/Cancelled |
PrimeSight 1997-04-18 |
 PRIMESIGHT 75277432 2215341 Dead/Cancelled |
PrimeSight 1997-04-18 |
 PRIMESIGHT 75277431 not registered Dead/Abandoned |
PrimeSight 1997-04-18 |
 PRIMESIGHT 75277430 2202209 Dead/Cancelled |
PrimeSight 1997-04-18 |
 PRIMESIGHT 75277428 2130777 Dead/Cancelled |
PrimeSight 1997-04-18 |
 PRIMESIGHT 75277427 2217829 Dead/Cancelled |
PrimeSight 1997-04-18 |
 PRIMESIGHT 74710771 2049870 Dead/Cancelled |
PRIMESIGHT 1995-08-03 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.