The following data is part of a premarket notification filed by Cytrellis Biosystems, Inc. with the FDA for Cytrellis Dermal Micro-coring System.
| Device ID | K202517 |
| 510k Number | K202517 |
| Device Name: | Cytrellis Dermal Micro-Coring System |
| Classification | Powered Microneedle Device |
| Applicant | Cytrellis Biosystems, Inc. 299C Washington St Woburn, MA 01801 |
| Contact | Karen H. Cronholm |
| Correspondent | Karen H. Cronholm Cytrellis Biosystems, Inc. 299C Washington St Woburn, MA 01801 |
| Product Code | QAI |
| CFR Regulation Number | 878.4430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-01 |
| Decision Date | 2021-07-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B933ELHPC010 | K202517 | 000 |
| B933ELHPC02 | K202517 | 000 |
| B933ELHPC02R0 | K202517 | 000 |
| B933ELCLP011 | K202517 | 000 |
| B933ELCON02 | K202517 | 000 |
| B933ELKIT010 | K202517 | 000 |
| B933ELSYS01 | K202517 | 000 |
| B933ELCON01R0 | K202517 | 000 |
| B933ELFTS01R0 | K202517 | 000 |
| B933ELHPC01R0 | K202517 | 000 |
| B933EL03N010 | K202517 | 000 |
| B933EL03N011 | K202517 | 000 |
| B933ELCCV01 | K202517 | 000 |
| B933ELCON010 | K202517 | 000 |
| B933ELFTS010 | K202517 | 000 |
| B933ELCON02R0 | K202517 | 000 |