The following data is part of a premarket notification filed by Jana Medical with the FDA for Laparoscopic Surgical Instrument.
| Device ID | K924028 |
| 510k Number | K924028 |
| Device Name: | LAPAROSCOPIC SURGICAL INSTRUMENT |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | JANA MEDICAL RT. 507 BOX J Greentown, PA 18426 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-11 |
| Decision Date | 1993-06-18 |