The following data is part of a premarket notification filed by Renovo, Inc. with the FDA for Reprocessed Covidien Trocar.
| Device ID | K172093 |
| 510k Number | K172093 |
| Device Name: | Reprocessed Covidien Trocar |
| Classification | Laparoscope, General & Plastic Surgery, Reprocessed |
| Applicant | Renovo, Inc. 340 SW Columbia St. Bend, OR 97702 |
| Contact | Mark K. Wells |
| Correspondent | Robert V. Packard Medical Device Academy, Inc. 345 Lincoln Hill Rd. Shrewsbury, VT 05738 |
| Product Code | NLM |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-11 |
| Decision Date | 2017-10-05 |
| Summary: | summary |