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
FDA 510(k) clearance K201756 · decided 2020-09-25
Clearance details
- K-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
- Applicant
- Stryker Sustainability Solutions
- Decision
- Substantially Equivalent
- Date received
- 2020-06-29
- Decision date
- 2020-09-25
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- HIH
- Device class
- 2
- Regulation number
- 884.1690
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Tempe, AZ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Stryker Sustainability Solutions
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.