K233500
- 510(k) number
- K233500
- Device name
- Benesta Tissue Removal Device
- Applicant
- Caldera Medical, Inc. CA · US
- Product code
- HIH — Hysteroscope (And Accessories)
- Decision date
- 2023-11-30
- Date received
- 2023-10-31
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Obstetrics/Gynecology
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K233500
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.