ENDOFLATOR +
FDA 510(k) clearance K250388 · decided 2025-09-22
Clearance details
- K-number
- K250388
- Device name
- ENDOFLATOR +
- Applicant
- Karl Storz SE & CO. KG
- Decision
- Substantially Equivalent
- Date received
- 2025-02-11
- Decision date
- 2025-09-22
- Days to decision
- 223 days
- Clearance type
- Traditional
- Product code
- HIF
- Device class
- 2
- Regulation number
- 884.1730
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Tuttlingen, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.