Manufacturer
Baylis Medical Technologies, Inc.PrecisePath™ Radiofrequency Puncture Generator and PrecisePath™ Footswitch
Baylis Medical Technologies, Inc.
Country / Region:Canada (CA)Submission type:Traditional
Product code GEI· 21 CFR 878.4400
Product code
GEI
21 CFR 878.4400
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K250275
- Device name
- PrecisePath™ Radiofrequency Puncture Generator and PrecisePath™ Footswitch
- Country / Region
- Canada(CA)
- Product code
- GEI
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4400
- Date received
- 2025-01-31
- Decision date
- 2025-10-28
- Submission type
- Traditional
- Technology type
- RF Generator(AI inferred)
- Clinical applications
- Surgery
- Primary application
- Surgery
- Classification source
- AI classified
Indications for Use
The PrecisePath Radiofrequency Puncture Generator and Footswitch (optional accessory) is indicated for use in general surgical procedures to cut and coagulate soft tissues.
Intended Use
The PrecisePath Radiofrequency Puncture Generator and Footswitch (optional accessory) is indicated for use in general surgical procedures to cut and coagulate soft tissues.
Device Description
The PrecisePath Radiofrequency (RF) Puncture Generator is indicated for use in general surgical procedures to cut and coagulate soft tissue. It is designed to be used by trained medical professionals, to provide radiofrequency (RF) current for creating controlled punctures with compatible Baylis RF devices in a monopolar mode. This continuous or pulsed RF current is output at a fixed frequency within 450 kHz to 480 kHz. The PrecisePath Footswitch (optional accessory) may be used as an alternative to the on/off button on the generator user interface by which the user can start and stop the delivery of RF energy. The PrecisePath RF Puncture Generator is compatible with separately cleared Baylis radiofrequency devices and connector cables, off-the-shelf return (dispersive) electrodes that meet or exceed IEC 60601-2-2:2017, and the PrecisePath footswitch (optional accessory).
Summary parsed at:2026-06-20 17:47:44 UTC
Predicate devices
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K250275 references 1 predicate/reference device
Cited as predicate
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