The following data is part of a premarket notification filed by Teleflex Medical, Inc. with the FDA for Percuvance(r) Percutaneous Surgical System.
| Device ID | K143299 |
| 510k Number | K143299 |
| Device Name: | Percuvance(R) Percutaneous Surgical System |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Teleflex Medical, Inc. 2917 Weck Drive Research Triangle Park, NC 27709 |
| Contact | Holly Hallock |
| Correspondent | Holly Hallock Teleflex Medical, Inc. 2917 Weck Drive Research Triangle Park, NC 27709 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-17 |
| Decision Date | 2015-01-21 |
| Summary: | summary |