The following data is part of a premarket notification filed by Spirus Medical, Inc. with the FDA for Endo-ease Endoscopic Overtube.
| Device ID | K052084 |
| 510k Number | K052084 |
| Device Name: | ENDO-EASE ENDOSCOPIC OVERTUBE |
| Classification | Endoscopic Access Overtube, Gastroenterology-urology |
| Applicant | SPIRUS MEDICAL, INC. 5 WHITCOMB AVENUE Ayer, MA 01432 |
| Contact | Pamela Papineau |
| Correspondent | Pamela Papineau SPIRUS MEDICAL, INC. 5 WHITCOMB AVENUE Ayer, MA 01432 |
| Product Code | FED |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-02 |
| Decision Date | 2005-09-14 |
| Summary: | summary |