The following data is part of a premarket notification filed by Teleflex Medical, Inc. with the FDA for Percuvance Percutaneous Surgical System.
| Device ID | K153063 |
| 510k Number | K153063 |
| Device Name: | PERCUVANCE PERCUTANEOUS SURGICAL SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Teleflex Medical, Inc. 3015 Carrington Mill Blvd Morrisville, NC 27560 |
| Contact | Holly Hallock |
| Correspondent | Holly Hallock Teleflex Medical, Inc. 3015 Carrington Mill Blvd Morrisville, NC 27560 |
| Product Code | GEI |
| Subsequent Product Code | GCJ |
| Subsequent Product Code | GDO |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-22 |
| Decision Date | 2016-04-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 34026704582939 | K153063 | 000 |
| 24026704582819 | K153063 | 000 |
| 24026704582826 | K153063 | 000 |
| 34026704582830 | K153063 | 000 |
| 34026704582847 | K153063 | 000 |
| 34026704582854 | K153063 | 000 |
| 14026704582867 | K153063 | 000 |
| 14026704582874 | K153063 | 000 |
| 34026704582885 | K153063 | 000 |
| 34026704582892 | K153063 | 000 |
| 24026704582901 | K153063 | 000 |
| 34026704582915 | K153063 | 000 |
| 34026704582922 | K153063 | 000 |
| 34026704582809 | K153063 | 000 |