# P000053: Ams Sphincter 800 Urinary Control System

- Pathway: PMA
- Applicant: Boston Scientific Corp
- Decided: Jun 14, 2001 after 177 days
- Product code: EZY (Device, Incontinence, Mechanical/Hydraulic)
- Device class: 3
- Regulation: 21 CFR 876.5280
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Oct 28, 2024 · Class II · Z-0531-2025: Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098)
- Oct 28, 2024 · Class II · Z-0530-2025: Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098)
- Jul 19, 2019 · Class II · Z-2442-2019: Mislabled: AMS 800 occlusive cuff labeled as 4.5 cm was a length of 4.0 cm and therefore..
- Mar 1, 2013 · Class II · Z-1280-2013: American Medical Systems, Inc. is initiating a recall on two components of the AMS 800¿ Urinary Control System, Control Pump & Pressure-Regulating Balloon. These products were released despite not mee
- Mar 1, 2013 · Class II · Z-1279-2013: American Medical Systems, Inc. is initiating a recall on two components of the AMS 800¿ Urinary Control System, Control Pump & Pressure-Regulating Balloon. These products were released despite not mee
- May 9, 2011 · Not classified · Z-2669-2011: American Medical Systems is recalling all unexpired AMS 800 and AMS Acticon Neosphincter Control Pumps. Based upon a review of our product test procedures, we are unable to confirm that all Control Pu

Source page: https://510kreport.com/device/P000053
Methodology: https://510kreport.com/methodology