Endoeye HD II (WA50040A, WA50042A, WA50050A, WA50052A)
FDA 510(k) K190744 · Olympus Winter & Ibe GmbH
510(k) numberK190744
Submission
- Device name
- Endoeye HD II (WA50040A, WA50042A, WA50050A, WA50052A)
- Applicant
- Olympus Winter & Ibe GmbH
Hamburg, DE - Received
- March 22, 2019
- Decision date
- August 29, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| K250939 | SIRIUS Endoscope System (PR-SI-1230)HET · Traditional | Precision Robotics (Hong Kong) Limited | 08/29/2025SE |
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| K221642 | SIRIUS Endoscope SystemHET · Traditional | Precision Robotics (Hong Kong) Limited | 12/12/2022SE |
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| K201832 | Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5HET · Traditional | Olympus Medical Systems Corp. | 09/17/2021SE |
| K210104 | SurroundScope SystemHET · Traditional | 270surgical , Ltd. | 07/08/2021SE |
| K201617 | TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control…HET · Traditional | Schoelly Fiberoptic GmbH | 03/12/2021SE |
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| K200638 | LAP-iX Suction IrrigationHET · Special | Sejong Medical Co., Ltd. | 04/03/2020SE |
| K190190 | WV1 EndoscopeHET · Traditional | 270surgical , Ltd. | 11/01/2019SE |
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| K260649 | OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 19.8 Fr.…FAJ · Traditional | 05/21/2026SE |
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| K231777 | Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories:…GEI · Traditional | 08/18/2023SE |
| K221522 | HF-cables (resusable)GEI · Traditional | 01/19/2023SE |
| K223183 | Light-Guide CablesHBI · Traditional | 01/13/2023SE |
| K213207 | Sheath, Stopcock AccessoryHIH · Traditional | 12/22/2021SE |
| K203492 | Instrument tray, for semi-rigid ureteroscopeKCT · Traditional | 09/15/2021SE |
| K210651 | Resection Electrodes with HF cableFAS · Traditional | 08/03/2021SE |
| K203682 | Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and…GEI · Traditional | 05/17/2021SE |
| K203277 | Electrosurgical Generator ESG-410, Foot Switches, PK Cutting ForcepsGEI · Traditional | 04/28/2021SE |
Questions and answers
When was Endoeye HD II (WA50040A, WA50042A, WA50050A, WA50052A) cleared by the FDA?
Endoeye HD II (WA50040A, WA50042A, WA50050A, WA50052A) (K190744) received a 510(k) decision of Substantially Equivalent on August 29, 2019, 160 days after the submission was received.
What is the product code of K190744?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.