MyoSure MANUAL Tissue Removal Device
FDA 510(k) clearance K173901 · decided 2018-05-08
Clearance details
- K-number
- K173901
- Device name
- MyoSure MANUAL Tissue Removal Device
- Applicant
- Hologic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-12-22
- Decision date
- 2018-05-08
- Days to decision
- 137 days
- Clearance type
- Traditional
- Product code
- HIH
- Device class
- 2
- Regulation number
- 884.1690
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Malborough, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.
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