The following data is part of a premarket notification filed by Applied Medical Resources Corporation with the FDA for Alexis Contained Extraction System.
| Device ID | K211043 |
| 510k Number | K211043 |
| Device Name: | Alexis Contained Extraction System |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Applied Medical Resources Corporation 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 |
| Contact | Apeksha Shanbhag |
| Correspondent | Apeksha Shanbhag Applied Medical Resources Corporation 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-08 |
| Decision Date | 2022-03-31 |