EXPLORER LIVER (PASSIVE TRACKING)
FDA 510(k) clearance K101979 · decided 2011-02-09
Clearance details
- K-number
- K101979
- Device name
- EXPLORER LIVER (PASSIVE TRACKING)
- Applicant
- Pathfinder Therapeutics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-07-14
- Decision date
- 2011-02-09
- Days to decision
- 210 days
- Clearance type
- Special
- Product code
- OEW
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Nashville, TN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CAS-One Liver (K143024) | Cascination AG | 2015-04-28 |
| LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEM (K093494) | Pathfinder Therapeutics, Inc. | 2010-03-30 |
| LINASYS (K071063) | Pathfinder Therapeutics, Inc. | 2007-12-20 |
Recalls involving this device
No recalls on record reference this clearance.