The following data is part of a premarket notification filed by Bpendo, Llc with the FDA for Insufflation Retention Device.
| Device ID | K213773 |
| 510k Number | K213773 |
| Device Name: | Insufflation Retention Device |
| Classification | Colonoscope And Accessories, Flexible/rigid |
| Applicant | Bpendo, LLC 216 Foreman Circle Norman, OK 73069 |
| Contact | Robert Holbrook |
| Correspondent | James Fentress Gilero, LLC 635 Davis Drive STE 100 Morrisville, NC 27560 |
| Product Code | FDF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-02 |
| Decision Date | 2022-07-21 |