# K180086: Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Acmi, Inc.
- Decided: Mar 8, 2018 after 55 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K974788 (1998). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143609: Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter, Olympus Surgical Technologies America (2015) Summary page 4.
- K112994: Cre Ditatation Ballon, Boston Scientific Corporation (2012) Summary page 4.

## Recalls of this device
- Sep 13, 2024 · Class II · Z-0225-2025: Mislabeled Glo Cath Label (attached to the device) states: 11 mm, 12 mm, 13 mm however the balloon is 8.5mm, 9.5mm and 10.5 mm and may result in prolonged surgery. All other labeling is correct for th
- Nov 10, 2023 · Class II · Z-0935-2024: Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
- Nov 10, 2023 · Class II · Z-0933-2024: Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
- Nov 10, 2023 · Class II · Z-0936-2024: Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
- Nov 10, 2023 · Class II · Z-0939-2024: Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
- Nov 10, 2023 · Class II · Z-0941-2024: Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
- Nov 10, 2023 · Class II · Z-0942-2024: Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
- Nov 10, 2023 · Class II · Z-0934-2024: Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
- Nov 10, 2023 · Class II · Z-0938-2024: Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
- Nov 10, 2023 · Class II · Z-0944-2024: Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
- Nov 10, 2023 · Class II · Z-0937-2024: Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
- Nov 10, 2023 · Class II · Z-0940-2024: Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
- Nov 10, 2023 · Class II · Z-0943-2024: Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.

## Indications for use
The Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheters are indicated for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract. It is also indicated in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy.

Source page: https://510kreport.com/device/K180086
Methodology: https://510kreport.com/methodology