The following data is part of a premarket notification filed by Surgical Instrument Service And Savings (dba Medline Renewal with the FDA for Medline Renewal Reprocessed Versaport V2 Bladeless Optical Trocars.
| Device ID | K153258 |
| 510k Number | K153258 |
| Device Name: | Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars |
| Classification | Laparoscope, General & Plastic Surgery, Reprocessed |
| Applicant | Surgical Instrument Service And Savings (dba Medline ReNewal 2747 SW 6th St. Redmond, OR 97756 |
| Contact | Brandi J Panteleon |
| Correspondent | Brandi J Panteleon Surgical Instrument Service And Savings (dba Medline ReNewal 2747 SW 6th St. Redmond, OR 97756 |
| Product Code | NLM |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-10 |
| Decision Date | 2016-04-05 |
| Summary: | summary |