The following data is part of a premarket notification filed by Surgeons Choice, Inc. with the FDA for Ila(inverted Linear Anastomosis) Stapler.
| Device ID | K813170 |
| 510k Number | K813170 |
| Device Name: | ILA(INVERTED LINEAR ANASTOMOSIS) STAPLER |
| Classification | Stapler, Surgical |
| Applicant | SURGEONS CHOICE, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GAG |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-11-17 |
| Decision Date | 1982-02-12 |