Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter, Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, Multipurpose Drainage Catheters and Sets— 510(k) K173035
Substantially EquivalentCook Incorporated
FDA 510(k) clearance K173035 for Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter, Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, Multipurpose Drainage Catheters and Sets, Substantially Equivalent on 2018-05-01. Applicant: Cook Incorporated. Device class: 2.
Clearance details
- Applicant
- Cook Incorporated
- Product code
- Code FGE
- Device class
- Class 2
- Regulation
- 21 CFR 876.5010
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bloomington, IN, US
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More clearances from Cook Incorporated
view allAdverse events under product code FGE
product code FGE- Death
- 52
- Injury
- 2,347
- Malfunction
- 9,798
- Other
- 1
- Total
- 12,198
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 K173035
K-number listed on FDA's recall record- Z-1786-2026 — COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, Order Number G29775
- Z-2222-2024 — Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter ULT16.0-38-25-P-6S-MCL-HC--Intended for percutaneous drainage in a variety of drainage applications (e.g., nephrostomy, biliary and abscess), either by direct stick or Seldinger access technique. ORDER NUMBER: GPN: G09230
- Z-2223-2024 — Ultrathane Cook-Cope Type Locking Loop Multipurpose Drainage Catheter-ULT12.0-38-45-P-6S-CLM-RH-ntended for percutaneous drainage in a variety of drainage applications (e.g., nephrostomy, biliary and abscess), either by direct stick or Seldinger access technique ORDER NUMBER: GPN:G09767
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K173035.
Data sourced from openFDA. This site is unofficial and independent of the FDA.