The following data is part of a premarket notification filed by Teleflex Medical, Inc. with the FDA for Percuvance Percutaneous Surgical System.
| Device ID | K181852 |
| 510k Number | K181852 |
| Device Name: | Percuvance Percutaneous Surgical System |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Teleflex Medical, Inc. 3015 Carrington Mill Blvd Morrisville, NC 27560 |
| Contact | Kim Campbell |
| Correspondent | Kim Campbell 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 | 2018-07-11 |
| Decision Date | 2018-10-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 44026704640254 | K181852 | 000 |
| 44026704640131 | K181852 | 000 |
| 34026704640141 | K181852 | 000 |
| 44026704640155 | K181852 | 000 |
| 44026704640162 | K181852 | 000 |
| 34026704640172 | K181852 | 000 |
| 34026704640189 | K181852 | 000 |
| 34026704640196 | K181852 | 000 |
| 34026704640202 | K181852 | 000 |
| 44026704640216 | K181852 | 000 |
| 44026704640223 | K181852 | 000 |
| 34026704640233 | K181852 | 000 |
| 34026704640240 | K181852 | 000 |
| 44026704640124 | K181852 | 000 |