The following data is part of a premarket notification filed by Scanlan Intl., Inc. with the FDA for Needle Driver.
| Device ID | K780255 |
| 510k Number | K780255 |
| Device Name: | NEEDLE DRIVER |
| Classification | Driver, Surgical, Pin |
| Applicant | SCANLAN INTL., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GFC |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-02-16 |
| Decision Date | 1978-04-18 |