The following data is part of a premarket notification filed by Axya Medical, Inc. with the FDA for Axya Medical, Inc. Automatic Suturing And Ligating System-(asls).
| Device ID | K980988 |
| 510k Number | K980988 |
| Device Name: | AXYA MEDICAL, INC. AUTOMATIC SUTURING AND LIGATING SYSTEM-(ASLS) |
| Classification | Needle, Suturing, Disposable |
| Applicant | AXYA MEDICAL, INC. 12 SOUTH ST. Marblehead, MA 01945 |
| Contact | Howard L Schrayer |
| Correspondent | Howard L Schrayer AXYA MEDICAL, INC. 12 SOUTH ST. Marblehead, MA 01945 |
| Product Code | GAB |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-17 |
| Decision Date | 1998-05-11 |
| Summary: | summary |