PERCUTANEOUS RETROGRADE NEPHROSTOMY— 510(k) K833762
Substantially EquivalentVpi
FDA 510(k) clearance K833762 for PERCUTANEOUS RETROGRADE NEPHROSTOMY, Substantially Equivalent on 1984-02-10. Applicant: Vpi. Device class: Unclassified.
Clearance details
- Applicant
- Vpi
- Product code
- Code LJE
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
Recent devices under product code LJE
view all- K250448 — Disposable Percutaneous Nephrostomy Dilatation Kit
- 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
More clearances from Vpi
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 →
Recalls naming K833762
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K833762.
Data sourced from openFDA. This site is unofficial and independent of the FDA.