Ethicon Endo-Surgery Enseal G2 Cordless Tissue Sealers
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Enseal EUDAMEDFDA UDI
- Generic Name
- Open-surgery electrosurgical handpiece/electrode, bipolar, single-use FDA UDI
- Device Name
- ENSEAL G2 Articulating Tissue Sealer EUDAMEDENSEAL X1 Tissue Sealer EUDAMEDEnseal Laparoscopic Tissue Sealer G2 Articulating Straight Jaw for use with G2 Generator 5mm Diameter 35cm Shaft length FDA UDIEnseal Laparoscopic Tissue Sealer G2 Articulating Straight Jaw for use with G2 Generator 5mm Diameter 45cm Shaft length FDA UDIENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft Length FDA UDI
- Model / Reference
- NSLG2S35A EUDAMEDFDA UDINSLG2S45A EUDAMEDFDA UDINSLX145C EUDAMEDFDA UDI
- Description
- Enseal Laparoscopic Tissue Sealer G2 Articulating Straight Jaw for use with G2 Generator 5mm Diameter 35cm Shaft length FDA UDIEnseal Laparoscopic Tissue Sealer G2 Articulating Straight Jaw for use with G2 Generator 5mm Diameter 45cm Shaft length FDA UDIENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft Length FDA UDI
Identifiers
- Catalog Number
- NSLG2S35A FDA UDINSLG2S45A FDA UDINSLX145C FDA UDI
- Primary DI / UDI-DI
- 10705036014515 EUDAMEDFDA UDI10705036014560 EUDAMEDFDA UDI10705036015499 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705036a0007575 EUDAMED0705036a0008578 EUDAMED
- 510(k) Number
- K123212 FDA 510(k)
- FDA Product Code
- PDG FDA 510(k)GEI FDA UDIHGI FDA UDI
- EMDN Code
- K0201010201,K0201010202 EUDAMED
- GMDN Term
- Open-surgery electrosurgical handpiece/electrode, bipolar, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 878.4400 FDA 510(k)
- Regulation Number
- 878.4400 FDA 510(k)FDA UDI884.4120 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
Yes
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
The Electrosurgical Vessel and/or Tissue Sealer with Built-In Generator is a device designed to seal and divide soft tissue during surgical procedures. It uses controlled thermal energy to create precise, secure seals in blood vessels and tissue, reducing the risk of bleeding and minimizing trauma to surrounding structures.
These cordless tissue sealers are intended for use in general and plastic surgery settings. Supplied sterile and intended for single-use, they are classified as Class II devices under FDA regulations (878.4400) and comply with the Medical Device Directive (MDD) and Medical Device Regulation (MDR). The device is available in a cordless configuration and is authorized via FDA 510(k) clearance (K123212) with a traditional review pathway.
Frequently asked questions
Are these tissue sealers designed for use in specific surgical specialties, and if so, which ones?
Yes, these cordless tissue sealers are specifically designed for use in general and plastic surgery settings. The device’s intended use aligns with these specialties, as indicated by its FDA 510(k) clearance under the General, Plastic Surgery advisory committee category (SU). This means they are engineered to assist in sealing and dividing soft tissue during procedures common in these fields, such as vascular or reconstructive surgeries.
How are these devices supplied, and what does that mean for surgical workflows?
The ETHICON ENDO-SURGERY ENSEAL G2 cordless tissue sealers are supplied sterile and intended for single-use only. This design ensures no risk of cross-contamination between patients and simplifies workflows by eliminating the need for reprocessing or sterilization between cases. Clinicians can open the package, use the device, and then safely dispose of it after a single procedure.
What does the cordless configuration mean for surgical flexibility, and how does it compare to traditional electrosurgical devices?
The cordless configuration provides greater mobility and maneuverability during surgery, as it eliminates the need for a power cord or external generator. This is particularly useful in tight or hard-to-reach areas of the surgical field, where traditional corded devices might limit movement. The built-in generator ensures consistent performance without requiring additional equipment, making it a convenient alternative for procedures where cord management could be cumbersome.
What regulatory pathways have been followed for this device, and what does that imply about its safety and compliance?
The device has undergone FDA 510(k) clearance via a traditional review pathway, with a decision code of SESE (Substantially Equivalent). This means the FDA determined it is as safe and effective as a legally marketed predicate device. Additionally, it complies with the Medical Device Directive (MDD) and Medical Device Regulation (MDR), ensuring adherence to stringent European regulatory standards. These pathways collectively imply rigorous evaluation of its performance, safety, and compliance with global medical device regulations.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K123212 | Class II | Active |
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Manufacturer
- Manufacturer
- Ethicon Endo-Surgery, LLC
Sources (7)
- FDA 510(k) K123212 24 fields · synced Sep 18, 2026
- FDA UDI 6c26778d-0c35-4b6e-8d33-3ca6514560f5 36 fields · synced May 29, 2026
- FDA UDI 1c22be53-5282-43d7-a636-304599ff658f 36 fields · synced May 30, 2026
- FDA UDI 4c7b11bc-5961-4844-be24-ae3740bfebcd 36 fields · synced May 30, 2026
- EUDAMED deeee602-6114-4084-9fcd-e4ba720c532b 61 fields · synced Jul 11, 2026
- EUDAMED 8868c4e6-0e61-4c21-bfa3-3169f8afb194 61 fields · synced Jul 14, 2026
- EUDAMED 960deaa7-1e49-41a3-9dce-9e7a50341288 61 fields · synced Jul 17, 2026