TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU))
FDA 510(k) clearance K201617 · decided 2021-03-12
Clearance details
- K-number
- K201617
- Device name
- TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU))
- Applicant
- Schoelly Fiberoptic GmbH
- Decision
- Substantially Equivalent
- Date received
- 2020-06-15
- Decision date
- 2021-03-12
- Days to decision
- 270 days
- Clearance type
- Traditional
- Product code
- HET
- Device class
- 2
- Regulation number
- 884.1720
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Denzlingen, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.