# K173035: Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter, Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, Multipurpose Drainage Catheters and Sets

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: May 1, 2018 after 215 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K944290 (1994). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152069: Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, Exodus Believe Biliary Drainage Catheter, Navilyst Medical, Inc. (2015) Summary page 6.

## Most influential descendants
- K191498: Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc (2020), 0 descendants of its own

## Recalls of this device
- Mar 5, 2026 · Class II · Z-1786-2026: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- May 15, 2024 · Class II · Z-2223-2024: Product labels state the incorrect expiration dates that extends beyond their true expiration date
- May 15, 2024 · Class II · Z-2222-2024: Product labels state the incorrect expiration dates that extends beyond their true expiration date

## Indications for use
The Gordon Large-Bore Curved Drainage Catheter is intended for abscess drainage. The Nephrostomy Pigtail Drainage Catheter and Percutaneous Nephrostomy Set are intended for external urine drainage from the renal pelvis. The Pigtail Drainage Catheter Needle Set is intended for percutaneous external drainage in multiple applications (e.g., nephrostomy, abscess drainage and other abdominal cavity drainage procedures). The Multipurpose Drainage Catheters and Sets are intended for percutaneous drainage in a variety of drainage applications (e.g., nephrostomy, biliary and abscess), either by direct stick or Seldinger access technique.

Source page: https://510kreport.com/device/K173035
Methodology: https://510kreport.com/methodology