Surgitek Percutaneous Arnegrade Silitek
FDA 510(k) K831857 · Medical Engineering Corp.
510(k) numberK831857
Submission
- Device name
- Surgitek Percutaneous Arnegrade Silitek
- Applicant
- Medical Engineering Corp.
Mchenry, IL, US - Received
- June 9, 1983
- Decision date
- August 11, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FAD – Stent, Ureteral
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4620
- Specialty
- Gastroenterology, Urology
- Implant
- Yes
Other 510(k)s with product code FAD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251890 | Disposable Ureteral StentsFAD · Traditional | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 02/20/2026SE |
| K251469 | Endura Ureteral Stent and Stent SetFAD · Traditional | Cathegenix (Xiamen) Co., Ltd. | 12/19/2025SESK |
| K243039 | Ureteral Stents (AF-D series)FAD · Traditional | Alton (Shanghai) Medical Instruments Co., Ltd. | 06/18/2025SE |
| K243830 | Disposable ureteral stentFAD · Traditional | Shenzhen Trious Medical Technology Co., Ltd. | 05/14/2025SE |
| K250824 | Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive…FAD · Special | Boston Scientific Corporation | 04/15/2025SE |
| K232920 | RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit…FAD · Traditional | Ureteral Stent Company | 03/22/2024SE |
| K211934 | APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL…FAD · Traditional | Boston Scientific Corporation | 11/10/2022SESK |
| K213185 | ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop…FAD · Traditional | Coloplast Corp. | 06/08/2022SESK |
| K213444 | RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit…FAD · Traditional | Ureteral Stent Company | 03/17/2022SE |
| K213186 | NovoFlow Reinforced Ureteral StentFAD · Traditional | Coloplast Corp. | 02/16/2022SESK |
More from Coloplast Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K934141 | Stand Alone CystometrogramFEN · Traditional | 11/18/1993SE |
| K905289 | Surgitek(R) Lubri-Flex(Tm) Ureteral StentFAD · Traditional | 03/13/1991SE |
| K903448 | Surgitek Tex-Span Textured Tissue ExpanderLCJ · Traditional | 01/14/1991SE |
| K902773 | Surgitek(R) Flexible Ureteroscopy Intro/Sheath SetFGB · Traditional | 07/16/1990SE |
| K884746 | Surgitek Flat T-SpanLCJ · Traditional | 08/10/1989SE |
| K883274 | Surgitek (R) Uroflow SystemFFG · Traditional | 02/08/1989SE |
| K881736 | Surgitek CO2 Delivery SystemFAP · Traditional | 08/11/1988SE |
| K880802 | Surgitek Articulating Ureteroscope Model SU-11FGB · Traditional | 05/26/1988SE |
| K880801 | Surgitek Flexible Ureteroscope SU-7 & SU-9FGB · Traditional | 05/26/1988SE |
| K842748 | Surgitek Reconstruc-Nipple Prosthesis · Traditional | 09/26/1984SE |
Questions and answers
When was Surgitek Percutaneous Arnegrade Silitek cleared by the FDA?
Surgitek Percutaneous Arnegrade Silitek (K831857) received a 510(k) decision of Substantially Equivalent on August 11, 1983, 63 days after the submission was received.
What is the product code of K831857?
The FDA product code is FAD – Stent, Ureteral, a Class II (moderate risk) device regulated under 21 CFR 876.4620.