Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5
FDA 510(k) K201832 · Olympus Medical Systems Corp.
510(k) numberK201832
Submission
- Device name
- Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5
- Applicant
- Olympus Medical Systems Corp.
Hachioji-Shi, JP - Received
- July 2, 2020
- Decision date
- September 17, 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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|---|---|---|---|
| K250939 | SIRIUS Endoscope System (PR-SI-1230)HET · Traditional | Precision Robotics (Hong Kong) Limited | 08/29/2025SE |
| K243821 | i-CutHET · Traditional | A.M.I. Agency For Medical Innovations GmbH | 04/25/2025SE |
| K221642 | SIRIUS Endoscope SystemHET · Traditional | Precision Robotics (Hong Kong) Limited | 12/12/2022SE |
| K210116 | Video Endoscopy System, 3D Video Endoscopy SystemHET · Traditional | Surgnova Healthcare Technologies (Zhejiang) Co.… | 10/13/2021SE |
| 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 |
| K200216 | 4K UHD Camera SystemHET · Traditional | Scivita Medical Technology Co., Ltd. | 08/21/2020SE |
| K200638 | LAP-iX Suction IrrigationHET · Special | Sejong Medical Co., Ltd. | 04/03/2020SE |
| K190190 | WV1 EndoscopeHET · Traditional | 270surgical , Ltd. | 11/01/2019SE |
| K190744 | Endoeye HD II (WA50040A, WA50042A, WA50050A, WA50052A)HET · Special | Olympus Winter & Ibe GmbH | 08/29/2019SE |
More from Olympus Winter & Ibe GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K262079 | 4K Camera Head OLYMPUS CH-S700-08-LBFET · Traditional | 09/10/2026SE |
| K260856 | Disposable Distal Attachment D-201-13404FDS · Traditional | 08/27/2026SE |
| K260824 | Gastrointestinal Videoscope Olympus GIF-2T1500FDS · Traditional | 08/27/2026SE |
| K260401 | Evis Eus Ultrasound Bronchofibervideoscope Olympus BF-UCP190F (BF-UCP190F)PSV · Traditional | 08/27/2026SE |
| K261183 | EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)ODG · Traditional | 07/31/2026SE |
| K254056 | THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…GEI · Traditional | 07/01/2026SE |
| K261260 | HD Camera Head OLYMPUS CH-S200-08-LBFET · Traditional | 06/24/2026SE |
| K260580 | Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090…PKL · Traditional | 05/21/2026SE |
| K252341 | Evis Exera III Bronchovideoscope (Olympus BF-Q190); Evis Exera III Bronchovideoscope…EOQ · Traditional | 04/23/2026SE |
| K252050 | Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241DEOB · Traditional | 03/20/2026SE |
Questions and answers
When was Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5 cleared by the FDA?
Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5 (K201832) received a 510(k) decision of Substantially Equivalent on September 17, 2021, 442 days after the submission was received.
What is the product code of K201832?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.