The following data is part of a premarket notification filed by Smith & Nephew with the FDA for S+n Laparoscopes, 4ko, Autoclavable, S+n Bariactric Laparoscopes, 4ko, Autoclavable.
| Device ID | K201198 |
| 510k Number | K201198 |
| Device Name: | S+N Laparoscopes, 4KO, Autoclavable, S+N Bariactric Laparoscopes, 4KO, Autoclavable |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Smith & Nephew 150 Minuteman Rd Andover, MA 01810 |
| Contact | Janice Haselton |
| Correspondent | Janice Haselton Smith & Nephew 150 Minuteman Rd Andover, MA 01810 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-04 |
| Decision Date | 2020-07-17 |