VERSACUT + TISSUE MORCELLATOR
FDA 510(k) clearance K133272 · decided 2014-05-13
Clearance details
- K-number
- K133272
- Device name
- VERSACUT + TISSUE MORCELLATOR
- Applicant
- Lumenis, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2013-10-24
- Decision date
- 2014-05-13
- Days to decision
- 201 days
- Clearance type
- Traditional
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Binyamina, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Lumenis VersaCut+ Tissue Morcellator GA-0007500 The Lumenis VersaCut / VersaCut+ Tissue Mo recall (Z-2770-2015) | Lumenis | 2015-09-16 |