Emprint CA20L2
by Covidien LP
Emprint CA20L2 is a microwave ablation system probe (FDA Class II) made by Covidien LP, cleared under FDA 510(k) K163105 on 6 Dec 2016 and listed in FDA GUDID since 28 Jun 2017 (UDI-DI 10884521706590), active as of 23 Oct 2026. 3 FDA recalls are linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
3 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10884521706590 | Date28 Jun 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK163105 | Date6 Dec 2016 | StatusActive |
Official records
- AccessGUDID record 10884521706590
- FDA 510(k) database K163105
Across registries
- FDA 510(k) K163105 decided 6 Dec 2016 Active
- FDA GUDID UDI-DI 10884521706590 listed 28 Jun 2017 Listed
Recalls
-
- Ongoing Z-0626-2019
- Ongoing Z-0625-2019
- Ongoing Z-0627-2019
The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.
Timeline
- Cleared FDA 510(k) K163105
- Listed FDA GUDID 10884521706590
- Recall initiated FDA recalls Z-0626-2019
- Recall initiated FDA recalls Z-0625-2019
- Recall initiated FDA recalls Z-0627-2019
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Emprint
- Generic name
- Microwave ablation system probe, non-powered
- Model / reference
- CA20L2
- Primary DI / UDI-DI
- 10884521706590
- 510(k) Number
- FDA product code
- NEY, GEI
- GMDN term
- Microwave ablation system probe, non-powered
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
- Size
- Length — 20 Centimeter
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