Percuvance(R) Percutaneous Surgical System
FDA 510(k) clearance K143299 · decided 2015-01-21
Clearance details
- K-number
- K143299
- Device name
- Percuvance(R) Percutaneous Surgical System
- Applicant
- Teleflexmedical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-11-17
- Decision date
- 2015-01-21
- Days to decision
- 65 days
- Clearance type
- Traditional
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Durham, NC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Teleflex Percuaneous Solutions, Gripper Grasper, Ref ML003EE, Rx Only Sterile Manufactured recall (Z-0058-2017) | Teleflex Medical | 2016-10-07 |
| Teleflex Percuaneous Solutions, Johans Grasper, Ref ML004EE, Rx Only Sterile Manufactured recall (Z-0059-2017) | Teleflex Medical | 2016-10-07 |