The following data is part of a premarket notification filed by Ortho Pared Instruments, Inc. with the FDA for Universal Suture Passer.
| Device ID | K812566 |
| 510k Number | K812566 |
| Device Name: | UNIVERSAL SUTURE PASSER |
| Classification | Needle, Suturing, Reusable |
| Applicant | ORTHO PARED INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GDL |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-09-09 |
| Decision Date | 1981-11-10 |