The following data is part of a premarket notification filed by Stryker Sustainability Solutions with the FDA for Reprocessed Endoscopic Trocars And Sleeves.
| Device ID | K201511 |
| 510k Number | K201511 |
| Device Name: | Reprocessed Endoscopic Trocars And Sleeves |
| Classification | Laparoscope, General & Plastic Surgery, Reprocessed |
| Applicant | Stryker Sustainability Solutions 1810 W. Drake Drive Tempe, AZ 85283 |
| Contact | Ramona Kulik |
| Correspondent | Ramona Kulik Stryker Sustainability Solutions 1810 W. Drake Drive Tempe, AZ 85283 |
| Product Code | NLM |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-05 |
| Decision Date | 2020-07-31 |