Manufacturer
Prana SurgicalPrana System
Country / Region:United States (US)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
- K253405
- Device name
- Prana System
- Company
- Prana Surgical
- Country / Region
- United States(US)
- Product code
- GEI
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4400
- Date received
- 2025-09-30
- Decision date
- 2026-04-01
- Submission type
- Traditional
- Technology type
- RF Ablation(AI inferred)
- Clinical applications
- SurgeryTissue Repair
- Primary application
- Surgery
- Classification source
- AI classified
Indications for Use
The Prana System is intended to remove tissue and control bleeding.
Intended Use
The Prana System is intended to remove tissue and control bleeding.
Device Description
The Prana System is a bipolar electrosurgical tool intended to be used with and connected via a cable to an electrosurgical generator. The Prana System is a sterile, single-use device that allows for localization and excision of tissue using cutting and energy delivery mechanisms.
Summary parsed at:2026-06-19 23:52:22 UTC