ST-E1 Overtube
FDA 510(k) K903842 · Olympus Corp.
510(k) numberK903842
Submission
- Device name
- ST-E1 Overtube
- Applicant
- Olympus Corp.
Lake Success, NY, US - Received
- August 21, 1990
- Decision date
- January 23, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FED – Endoscopic Access Overtube, Gastroenterology-Urology
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation.
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| K250132 | Ureteral Access SheathFED · Traditional | Zhejiang YiGao Medical Technology Co., Ltd. | 09/05/2025SE |
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| K251599 | Single-use Ureteral Access SheathFED · Special | Hunan Vathin Medical Instrument Co., Ltd. | 07/03/2025SE |
| K250585 | LumenaTM Ureteral Access SheathFED · Traditional | Cathegenix (Xiamen) Co., Ltd. | 06/27/2025SE |
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| K915402 | EW-10 and EW-20FEB · Traditional | 06/23/1995SN |
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Questions and answers
When was ST-E1 Overtube cleared by the FDA?
ST-E1 Overtube (K903842) received a 510(k) decision of Substantially Equivalent on January 23, 1991, 155 days after the submission was received.
What is the product code of K903842?
The FDA product code is FED – Endoscopic Access Overtube, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.