Manufacturer
Cnc TechnologiesDuoblade Plus SE (DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH); Duoblade Prime (DB1P, DB1P-T, DB1P-H, DB1P-TH)
Country / Region:Korea, Republic of (KR)Submission type:Special
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
- K252211
- Device name
- Duoblade Plus SE (DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH); Duoblade Prime (DB1P, DB1P-T, DB1P-H, DB1P-TH)
- Company
- Cnc Technologies
- Country / Region
- Korea, Republic of(KR)
- Product code
- GEI
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4400
- Date received
- 2025-07-15
- Decision date
- 2025-08-11
- Submission type
- Special
- Technology type
- RF Generator(AI inferred)
- Clinical applications
- SurgeryOther
- Primary application
- Surgery
- Classification source
- AI classified
Indications for Use
The Duoblade Plus SE (Models: DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH), and Duoblade Prime (Models: DB1P, DB1P-T, DB1P-H, DB1P-TH) are intended for general electrosurgical applications, including cutting and coagulation. These models are designed without shaft extension functionalities. The Model: DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH are compatible with the smoke evacuation system, removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
Intended Use
The Duoblade Plus SE (Models: DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH), and Duoblade Prime (Models: DB1P, DB1P-T, DB1P-H, DB1P-TH) are intended for general electrosurgical applications, including cutting and coagulation. These models are designed without shaft extension functionalities. The Model: DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH are compatible with the smoke evacuation system, removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
Device Description
The Duoblade Plus SE and Duoblade Prime are electrosurgical devices designed for cutting and coagulation. They utilize RF Monopolar Energy and are sterilized using EtO. The blade material is coated aluminum, and the devices are available in various models with integrated suction capabilities. The dimensions of the blades are 3.0 x 11.0 mm, and the devices are designed without shaft extension functionalities.
Summary parsed at:2026-06-20 17:50:32 UTC
Predicate devices
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Not ingested
K252211 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 K252211 as a predicate