The following data is part of a premarket notification filed by Surgical Direct, Inc. with the FDA for Surgical Direct Hand-held Laparoscopic Instruments.
| Device ID | K193018 |
| 510k Number | K193018 |
| Device Name: | Surgical Direct Hand-held Laparoscopic Instruments |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Surgical Direct, Inc. 909 South Woodland Blvd. Deland, FL 32720 |
| Contact | David Murray |
| Correspondent | E. J. Smith Smith Associates 1468 Harwell Avenue Crofton, MD 21114 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-29 |
| Decision Date | 2019-12-20 |