Manufacturer
Lagis Enterprise Co., Ltd.LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T)
Country / Region:Taiwan (TW)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
- K253134
- Device name
- LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T)
- Company
- Lagis Enterprise Co., Ltd.
- Country / Region
- Taiwan(TW)
- Product code
- GEI
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4400
- Date received
- 2025-09-25
- Decision date
- 2026-05-20
- Submission type
- Traditional
- Technology type
- Endoscopic Instrument(AI inferred)
- Clinical applications
- SurgeryTissue Repair
- Primary application
- Surgery
- Classification source
- AI classified
Indications for Use
The LAGIS Endoscopic Instruments- Scissors have applications in minimally invasive procedures for cutting and cauterization of tissue. The ENDOPATH™ Endoscopic Instruments have application in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection, and transection of tissue. Single Use Only
Intended Use
The LAGIS Endoscopic Instruments- Scissors have applications in minimally invasive procedures for cutting and cauterization of tissue. The ENDOPATH™ Endoscopic Instruments have application in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection, and transection of tissue.
Device Description
e different questions of safety and effectiveness. After analyzing all testing data and comparing it with the predicated device, it can be concluded that the LAGIS Endoscopic Instruments- Scissors is substantially equivalent to the
Summary parsed at:2026-06-19 06:02:41 UTC
Predicate devices
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Not ingested
K253134 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 K253134 as a predicate