The following data is part of a premarket notification filed by Trice Medical, Inc. with the FDA for Mi-eye 3 Needlescope With Cannula, Mi-tablet 3.
| Device ID | K212556 |
| 510k Number | K212556 |
| Device Name: | Mi-eye 3 Needlescope With Cannula, Mi-tablet 3 |
| Classification | Arthroscope |
| Applicant | Trice Medical, Inc. 40 General Warren Blvd, Suite 100 Malvern, PA 19355 |
| Contact | David Vancelette |
| Correspondent | David Vancelette Trice Medical, Inc. 40 General Warren Blvd, Suite 100 Malvern, PA 19355 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-13 |
| Decision Date | 2021-09-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857356008293 | K212556 | 000 |
| 00857356008286 | K212556 | 000 |
| 00857356008279 | K212556 | 000 |
| 00857356008262 | K212556 | 000 |
| 00857356008255 | K212556 | 000 |
| 00857356008248 | K212556 | 000 |
| 00857356008231 | K212556 | 000 |
| 00857356008224 | K212556 | 000 |