Submission Details
| 510(k) Number | K201617 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 15, 2020 |
| Decision Date | March 12, 2021 |
| Days to Decision | 270 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
Cleared
Traditional
TipVision Videoscope System (TipVision VideoScope 0?/30?; EleVision HD 2 Camera Control Unit (CCU))
Mar 2021
Decision
270d
Days
Class 2
Risk
About This 510(k) Submission
K201617 is an FDA 510(k) clearance for the TipVision Videoscope System (TipVision VideoScope 0?/30?; EleVision HD 2 Camera Control Unit (CCU)), a Laparoscope, Gynecologic (and Accessories) (Class II — Special Controls, product code HET), submitted by Schoelly Fiberoptic GmbH (Denzlingen, DE). The FDA issued a Cleared decision on March 12, 2021, 270 days after receiving the submission on June 15, 2020. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1720.
Device Classification
| Product Code | HET — Laparoscope, Gynecologic (and Accessories) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.1720 |
Manufacturer
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