Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set— 510(k) K181735
UnknownCook Incorporated
FDA 510(k) clearance K181735 for Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set, Unknown on 2019-03-27. Applicant: Cook Incorporated. Device class: Unclassified.
Clearance details
- Applicant
- Cook Incorporated
- Product code
- Code LJE
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Traditional
- Location
- Bloomington, IN, US
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More clearances from Cook Incorporated
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 K181735
K-number listed on FDA's recall record- Z-0105-2021 — Percutaneous Neonatal Pigtail Nephrostomy Set, Reference Part Number 080106, Order Number G14508. The set contains a 22 gage, 5 cm Chiba Needle; an 18 gage, 5 cm trocar needle; an .038-inch (.97 mm) diameter, 30 cm PTFE-coated stainless steel; a 5, 6, and 7 French, 10 cm radiopaque dilator; a 6 French, 7 cm radiopaque pigtail catheter; a retention disc with pull tie; and a 10 French, 10 cm clear, polyvinylchloride connecting tube with one-way stopcock.
- Z-0106-2021 — Pediatric Nephrostomy Stent Set, Reference Part Numbers 080208-S6 and 080208-S7, Order Numbers G15034 and G15035. The set contains a radiopaque pigtail catheter and stent, retention disc with pull tie, and a 10 French, 30 cm polyvinylchloride connecting tube with one-way stopcock.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K181735.
Data sourced from openFDA. This site is unofficial and independent of the FDA.