Surgiteks Percutaneous Antegrade All -
510(k) K830884
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK830884 | Date9 May 1983 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FAD
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.4620
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Surgiteks Percutaneous Antegrade All - is a ureteral stent, a tubular device designed to maintain patency of the ureter by providing a drainage pathway for urine from the kidney to the bladder. It is classified as a Class II medical device under FDA regulations and is intended for use in both urological and gastroenterological procedures, ensuring proper urinary flow in cases where obstruction or surgical intervention requires stenting.
This device is supplied sterile and intended for single-use, though reuse may be considered under controlled conditions as permitted by regulatory standards. It is classified under FDA regulation 876.4620 and has received a 510(k) clearance (K830884) for substantial equivalence. The stent is available in multiple sizes and configurations, as referenced by the associated FEI numbers, and is intended for use in clinical settings where percutaneous antegrade access is required. No specific MRI safety information is provided in the available data.