URESIL NEPHROSTOMY CATHETER— 510(k) K923097
Substantially EquivalentUresil Corp.
FDA 510(k) clearance K923097 for URESIL NEPHROSTOMY CATHETER, Substantially Equivalent on 1992-09-14. Applicant: Uresil Corp.. Device class: Unclassified.
Clearance details
- Applicant
- Uresil Corp.
- Product code
- Code LJE
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Skokie, IL, US
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More clearances from Uresil Corp.
view all- K003753 — GP GENERAL PURPOSE DRAINAGE SET, MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL, GP GENERAL PURPOSE DRAINAGE CATHE
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- K981344 — URESIL PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COATING
- K980282 — URESIL DILATOR WITH RADIOPAQUE MARKER
- K980889 — URESIL NEPHRO-URETERAL STENT
Adverse 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.