The following data is part of a premarket notification filed by Stryker Sustainability Solutions with the FDA for Reprocessed Myosure Tissue Removal Device, Reprocessed Myosure Reach Tissue Removal Device, Reprocessed Myosure Lite Tissue Removal Device, Reprocessed Myosure Xl Tissue Removal Device, Reprocessed Myosure Xl Tissue Removal Device For Fluent.
| Device ID | K201756 |
| 510k Number | K201756 |
| Device Name: | Reprocessed MyoSure Tissue Removal Device, Reprocessed MyoSure REACH Tissue Removal Device, Reprocessed MyoSure LITE Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device For Fluent |
| Classification | Hysteroscope (and Accessories) |
| Applicant | Stryker Sustainability Solutions 1810 W Drake Drive Tempe, AZ 85283 |
| Contact | Scott English |
| Correspondent | Scott English Stryker Sustainability Solutions 1810 W Drake Drive Tempe, AZ 85283 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-29 |
| Decision Date | 2020-09-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 37613327507141 | K201756 | 000 |
| 37613327507134 | K201756 | 000 |
| 37613327507127 | K201756 | 000 |
| 57613327507114 | K201756 | 000 |
| 37613327507103 | K201756 | 000 |