# K933200: Olympus PBD Stents

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Corp.
- Decided: Apr 5, 1995 after 643 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 3 cite it directly.
0 of 4 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
- K103478: Single Use Biliary Drainage Stent V (2011), 0 descendants of its own
- K060624: Marathon Stent with Fusion Technology (2006), 0 descendants of its own
- K021672: Pancreatic Drainage Tube (2003), 0 descendants of its own

## Recalls of this device
- Jan 4, 2021 · Class II · Z-1063-2021: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
- Jan 4, 2021 · Class II · Z-1064-2021: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
- Jan 4, 2021 · Class II · Z-1066-2021: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
- Jan 4, 2021 · Class II · Z-1065-2021: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Source page: https://510kreport.com/device/K933200
Methodology: https://510kreport.com/methodology