UROPASS URETERAL ACCESS SHEATH, MODEL 61224— 510(k) K051593
Substantially EquivalentAcmi Corporation
FDA 510(k) clearance K051593 for UROPASS URETERAL ACCESS SHEATH, MODEL 61224, Substantially Equivalent on 2005-09-02. Applicant: Acmi Corporation. Device class: 2.
Clearance details
- Applicant
- Acmi Corporation
- Product code
- Code KNY
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Southborough, MA, US
Recent devices under product code KNY
view allMore clearances from Acmi Corporation
view allRecalls naming K051593
K-number listed on FDA's recall record- Z-0364-2025 — Brand Name: UroPass Ureteral Access Sheaths Product Name: Ureteral Access Sheaths Model/Catalog Number: 61024BX, 61038BX, 61046BX, 61054BX, 61124BX, 61138BX, 61146BX, 61154BX, 61224BX, 61238BX, 61246BX, 61254BX, 61324BX, 61338BX, 61346BX, 61354BX Software Version: N/A Product Description: The Olympus UroPass Ureteral Access Sheath Set consists of a hydrophilic coated outer sheath and an inner tapered dilator intended to establish a conduit for the passage of endoscopes and retrieval devices into the ureter. The hydrophilic coating on the UroPass Ureteral Access Sheath eases passage and placement. Both the outer sheath and inner dilator are radio-opaque for ease of viewing radiographically. Intended for single use only. Component: N/A
- Z-2401-2023 — UroPass Ureteral Access Sheaths, 5 pieces/box
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K051593.
Data sourced from openFDA. This site is unofficial and independent of the FDA.