# K851962: Zimmon Biliary Stent Set

- Pathway: 510(k) (Traditional)
- Applicant: Wilson-Cook Medical, Inc.
- Decided: Dec 17, 1985 after 228 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 3 cite 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K040151: Oasis Biliary Stent Introduction System (2004), 5 descendants of its own
- K172044: Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Biliary Stent, Soehendra Tannenbaum Biliary Stent, Zimmon Biliary Stent, Guiding Catheter, Pushing catheter, Fusion pushing catheter, Stent Introducer Set, Fusion Oasis One Action Sent Introduction System, Zimmon Biliary Stent Set, Oasis One Action Stent Introduction System, Solus Double Pigtail Stent and Introduction System, Cotton-Huibregtse Biliary Stent Set, Cotton-Leung Biliary Stent Set, Oasis One Action S (2018), 3 descendants of its own
- K251658: Endoflux™ Biliary & Pancreatic Stent Sets (2026), 0 descendants of its own
- K230127: Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set, Biliary Plastic Stent Introducer/ short-wire compatible, Biliary Plastic Stent Set/ short-wire compatible (2023), 0 descendants of its own
- K213946: Compass BDS Biliary Stent (2022), 0 descendants of its own

## Recalls of this device
- Jul 2, 2008 · Not classified · Z-2332-2008: It is possible the stents inside CLSO-10-10, lot W2512492 were 5cm in length, instead of 10cm in length as listed on the product packaging label.
- Jul 2, 2008 · Not classified · Z-2331-2008: The product packaging label indicates the stent is 5cm, but the actual stent inside the packaging measures 10cm.
- Jun 9, 2005 · Not classified · Z-0940-05: The reorder number listed on the product label is inaccurate.
- Apr 21, 2004 · Not classified · Z-0908-04: The guiding catheter provided with the SIS-10 biliary stent introduction system may be a 5 French instead of the required 6 French guiding catheter.
- Dec 22, 2003 · Not classified · Z-0347-04: Mislabeling; Incorrect statement, Minimum Accessory Channel Size: 3.7mm, should state, Minimum Accessory Channel Size 4.2mm

Source page: https://510kreport.com/device/K851962
Methodology: https://510kreport.com/methodology