510(k) K173035 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter, Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, Multipurpose Drainage Catheters and Sets
| Applicant | Cook Incorporated, Bloomington IN, US |
| Decision | Substantially Equivalent, May 1, 2018 |
| Received | Sep 28, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173035
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 6, 2026 | Cook Incorporated COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, Order Number G29775 Open, Classified |
FGE | None listed |
| Jun 27, 2024 | Cook Incorporated 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 absce Open, Classified |
FGE | None listed |
| Jun 27, 2024 | Cook Incorporated 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 Open, Classified |
FGE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.