Manufacturer
SterisElectro Lube NXT
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
- K242773
- Device name
- Electro Lube NXT
- Company
- Steris
- Country / Region
- United States(US)
- Product code
- GEI
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4400
- Date received
- 2024-09-13
- Decision date
- 2025-04-15
- Submission type
- Traditional
- Technology type
- Other(AI inferred)
- Clinical applications
- Surgery
- Primary application
- Surgery
- Classification source
- AI classified
Indications for Use
Electro Lube™ NXT is a single patient use device used in open and minimally-invasive surgery to reduce tissue sticking and eschar on electrosurgical instruments, including robotic assisted electrosurgical instruments.
Intended Use
Electro Lube™ NXT is a single patient use device used in open and minimally-invasive surgery to reduce tissue sticking and eschar on electrosurgical instruments, including robotic-assisted electrosurgical instruments.
Device Description
Electro Lube NXT is a single-use sterile electrosurgical accessory device intended to be used on electrosurgical electrodes to reduce sticking. It is sterilized by irradiation and provided to the end user in an individual sterile barrier package with one bottle containing 4mL of the solution and one foam pad for application of the solution during use included in each pack. The foam pad includes an adhesive backing and barium filament strand of material for radiopacity.
Summary parsed at:2026-06-20 17:45:17 UTC
Predicate devices
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K242773 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 K242773 as a predicate