Probe Sheath for Adms & Capistrano Labs Transrec.
FDA 510(k) K896680 · Interson Corp.
510(k) numberK896680
Submission
- Device name
- Probe Sheath for Adms & Capistrano Labs Transrec.
- Applicant
- Interson Corp.
Pleasanton, CA, US - Received
- November 27, 1989
- Decision date
- February 14, 1990
- 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.
Other 510(k)s with product code FED
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260410 | Single Use Ureteral Access SheathFED · Special | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 09/11/2026SE |
| K261915 | Navigator Flex Ureteral Access Sheath SetFED · Traditional | Boston Scientific Corporation | 08/04/2026SE |
| K260965 | CVAC Aspiration SystemFED · Special | Calyxo, Inc. | 04/13/2026SE |
| K260521 | ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050…FED · Traditional | Zhuhai Pusen Medical Technology Co., Ltd. | 04/06/2026SE |
| K252572 | Prodeon Urethral Sheath SystemFED · Traditional | Prodeon Medical, Inc. | 10/07/2025SE |
| K250128 | Single Use Suction-Evacuation Ureteral Access SheathFED · Traditional | Anhui Happiness Workshop Medical Instruments… | 09/19/2025SE |
| K250132 | Ureteral Access SheathFED · Traditional | Zhejiang YiGao Medical Technology Co., Ltd. | 09/05/2025SE |
| K250695 | Single-use Ureteral Access SheathFED · Traditional | Shenzhen HugeMed Medical Technical Development… | 07/08/2025SE |
| 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 |
More from Cathegenix (Xiamen) Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K233734 | Interson USB Ultrasound SystemIYN · Special | 12/22/2023SE |
| K163443 | Interson USB Ultrasound SystemIYN · Traditional | 04/13/2017SE |
| K911116 | Interson Endocavity Probe/Kontron Ultrasound SystITX · Traditional | 12/20/1991SE |
| K911117 | Interson Endocavity Probe for Atl Ultrasound SystITX · Traditional | 12/17/1991SE |
| K911115 | Interson Transrectal Probe/Atl Ultrasound SystemITX · Traditional | 12/17/1991SE |
| K911113 | Interson Transrectal Probe/Kontron Ultrasound SystITX · Traditional | 12/17/1991SE |
| K911114 | Interson Endocavity Probe/Aloka Ultrasound SystemITX · Traditional | 11/19/1991SE |
| K911464 | Interson Disposable Biopsy NeedleIYO · Traditional | 09/27/1991SE |
| K900555 | Interson Multiplane Rectal Probe for Aloka Ultra.ITX · Traditional | 05/02/1990SE |
| K895725 | Biopsy Needle Guide for Adms Ultrasound ProbesFCG · Traditional | 11/06/1989SE |
Questions and answers
When was Probe Sheath for Adms & Capistrano Labs Transrec. cleared by the FDA?
Probe Sheath for Adms & Capistrano Labs Transrec. (K896680) received a 510(k) decision of Substantially Equivalent on February 14, 1990, 79 days after the submission was received.
What is the product code of K896680?
The FDA product code is FED – Endoscopic Access Overtube, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.