| Device Classification Name |
Labware, Assisted Reproduction
|
| 510(k) Number |
K262276 |
| Device Name |
Cyperus |
| Applicant |
| Contrario Medical, Inc. |
| 2450 Holcombe Blvd. |
| Suite 1420 |
|
Houston,
TX
77021
|
|
| Applicant Contact |
Albert Huang |
| Correspondent |
| DuVal & Associates |
| 825 Nicollet Mall |
| Suite 1820 |
|
Minneapolis,
MN
55402
|
|
| Correspondent Contact |
Allison Komiyama |
| Regulation Number | 884.6160 |
| Classification Product Code |
|
| Date Received | 07/06/2026 |
| Decision Date | 10/26/2026 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Obstetrics/Gynecology
|
| 510k Review Panel |
Obstetrics/Gynecology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|