The following data is part of a premarket notification filed by Covidien Llc with the FDA for Cytosponge Cell Collection Device.
| Device ID | K181020 |
| 510k Number | K181020 |
| Device Name: | Cytosponge Cell Collection Device |
| Classification | Esophagoscope (flexible Or Rigid) |
| Applicant | Covidien Llc 15 Hampshire Street Mansfield, MA 02048 |
| Contact | Rachel Silva |
| Correspondent | Rachel Silva Covidien Llc 15 Hampshire Street Mansfield, MA 02048 |
| Product Code | EOX |
| CFR Regulation Number | 874.4710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-17 |
| Decision Date | 2018-08-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521767789 | K181020 | 000 |