Pathway® 6340
by Prometheus Group of New Hampshire Limited, the
Pathway® 6340 is a Class II device made by Prometheus Group of New Hampshire Limited, the, listed in FDA GUDID since 26 Sep 2016 (UDI-DI 00852423006189), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00852423006189 | Date26 Sep 2016 | StatusListed |
Official records
- AccessGUDID record 00852423006189
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Pathway®
- Generic name
- Perineal orifice incontinence-control electrical stimulation system probe, single-use
- Model / Ref / Catalog
- 6340
- Primary DI / UDI-DI
- 00852423006189
- FDA product code
- KPI
- GMDN term
- Perineal orifice incontinence-control electrical stimulation system probe, single-use
- Device class
- Class II
- Regulation number
- 876.5320
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence).
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- InTone by INCONTROL MEDICAL, LLC
- UROSTYM by Laborie Medical Technologies Corp.
- Well-Life Probe Electrode for Stimulation/EMG Probe Model SA by Well-Life Healthcare, Inc.
- HPM-6000UF by BTL Industries, Inc.
- Everyway Incontinence Stimulation System by EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
- TS-700P CONTROL XP ELECTRICAL STIMULATOR by Myo/Kinetic Systems, Inc.
- Skylark Uro Probe by Skylark Device & Systems Co., Ltd.
- ApexMV by INCONTROL MEDICAL, LLC
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