The following data is part of a premarket notification filed by Vision-sciences, Inc. with the FDA for Endosheath.
| Device ID | K990354 |
| 510k Number | K990354 |
| Device Name: | ENDOSHEATH |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | VISION-SCIENCES, INC. 9 STRATHMORE RD. Natick, MA 01760 |
| Contact | Pamela Papineau |
| Correspondent | Pamela Papineau VISION-SCIENCES, INC. 9 STRATHMORE RD. Natick, MA 01760 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-05 |
| Decision Date | 1999-03-31 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ENDOSHEATH 86539305 5015565 Live/Registered |
COGENTIX MEDICAL, INC. 2015-02-19 |
![]() ENDOSHEATH 86490133 not registered Dead/Abandoned |
Encision, Inc. 2014-12-24 |
![]() ENDOSHEATH 74706949 2002713 Live/Registered |
COGENTIX MEDICAL, INC. 1995-07-27 |
![]() ENDOSHEATH 74427279 1849840 Dead/Cancelled |
COGENTIX MEDICAL, INC. 1993-08-23 |