TRUCLEAR MORCELLATOR SYSTEM
FDA 510(k) clearance K110038 · decided 2011-03-30
Clearance details
- K-number
- K110038
- Device name
- TRUCLEAR MORCELLATOR SYSTEM
- Applicant
- Smith & Nephew, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-01-06
- Decision date
- 2011-03-30
- Days to decision
- 83 days
- Clearance type
- Special
- Product code
- HIH
- Device class
- 2
- Regulation number
- 884.1690
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Andover, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
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|---|---|---|
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