The following data is part of a premarket notification filed by Conmed Corp. with the FDA for Asp-irrator.
| Device ID | K914997 |
| 510k Number | K914997 |
| Device Name: | ASP-IRRATOR |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | CONMED CORP. 310 BROAD ST. Utica, NY 13501 -1203 |
| Contact | Martin P Forte |
| Correspondent | Martin P Forte CONMED CORP. 310 BROAD ST. Utica, NY 13501 -1203 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-07 |
| Decision Date | 1992-01-07 |