Manufacturer
CnS Medical Co., Ltd.DELPHI System
Country / Region:Korea, Republic of (KR)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
- K242907
- Device name
- DELPHI System
- Company
- CnS Medical Co., Ltd.
- Country / Region
- Korea, Republic of(KR)
- Product code
- GEI
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4400
- Date received
- 2024-09-24
- Decision date
- 2025-06-06
- Submission type
- Traditional
- Technology type
- RF Ablation(AI inferred)
- Clinical applications
- SurgeryTissue Repair
- Primary application
- Surgery
- Classification source
- AI classified
Indications for Use
DELPHI System is indicated for coagulation and ablation of tissue and hemostasis of blood vessels during arthroscopic surgery. DELPHI System is designed for exclusive use with DELPHI PLUS or DISCORE bipolar electrode.
Intended Use
DELPHI System is indicated for coagulation and ablation of tissue and hemostasis of blood vessels during arthroscopic surgery. DELPHI System is designed for exclusive use with DELPHI PLUS or DISCORE bipolar electrode.
Device Description
DELPHI System is classified as an electrosurgical device for cutting and coagulation. It is intended for use in surgical procedures.
Summary parsed at:2026-06-20 17:45:25 UTC
Predicate devices
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Not ingested
K242907 references 1 predicate/reference device
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K242907 as a predicate