TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU))
FDA 510(k) K201617 · Schoelly Fiberoptic GmbH
510(k) numberK201617
Submission
- Device name
- TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU))
- Applicant
- Schoelly Fiberoptic GmbH
Denzlingen, DE - Received
- June 15, 2020
- Decision date
- March 12, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HET – Laparoscope, Gynecologic (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1720
- Specialty
- Obstetrics/Gynecology
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| K143673 | CMOS Video Nasopharyngoscope SystemEOB · Special | 03/04/2015SE |
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Questions and answers
When was TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU)) cleared by the FDA?
TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU)) (K201617) received a 510(k) decision of Substantially Equivalent on March 12, 2021, 270 days after the submission was received.
What is the product code of K201617?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.