Disposable Percutaneous Nephrostomy Dilatation Kit— 510(k) K250448
Substantially EquivalentShenzhen Trious Medical Technology Co., Ltd.
FDA 510(k) clearance K250448 for Disposable Percutaneous Nephrostomy Dilatation Kit, Substantially Equivalent on 2025-07-03. Applicant: Shenzhen Trious Medical Technology Co., Ltd.. Device class: Unclassified.
Clearance details
- Applicant
- Shenzhen Trious Medical Technology Co., Ltd.
- Product code
- Code LJE
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Recent devices under product code LJE
view all- K222705 — Introducer Needle
- K211911 — Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets
- K201165 — In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath
- K191498 — Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc
- K190903 — Lawson Retrograde Nephrostomy Wire Puncture Set
More clearances from Shenzhen Trious Medical Technology Co., Ltd.
view allAdverse events under product code LJE
product code LJE- Death
- 6
- Total
- 6
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.