Edge E1465-4NSB
by Covidien LP
Edge E1465-4NSB is a Class II device made by Covidien LP, cleared under FDA 510(k) K981916 on 28 Aug 1998 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 10884521175549), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10884521175549 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK981916 | Date28 Aug 1998 | StatusActive |
Official records
- AccessGUDID record 10884521175549
- FDA 510(k) database K981916
Across registries
- FDA 510(k) K981916 decided 28 Aug 1998 Active
- FDA GUDID UDI-DI 10884521175549 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K981916
- Listed FDA GUDID 10884521175549
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Edge
- Generic name
- Endoscopic electrosurgical electrode, monopolar, single-use
- Model / reference
- E1465-4NSB
- Primary DI / UDI-DI
- 10884521175549
- 510(k) Number
- FDA product code
- GEI
- GMDN term
- Endoscopic electrosurgical electrode, monopolar, single-use
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution
- Size
- Length — 4 Inch
Similar devices in this category
Other devices filed under Endoscopic electrosurgical electrode, monopolar, single-use.