The following data is part of a premarket notification filed by Advanced Surgical Intervention, Inc. with the FDA for Asi Cystoscope Sheath, Grasping Forceps & For.body.
| Device ID | K895182 |
| 510k Number | K895182 |
| Device Name: | ASI CYSTOSCOPE SHEATH, GRASPING FORCEPS & FOR.BODY |
| Classification | Cystoscope And Accessories, Flexible/rigid |
| Applicant | ADVANCED SURGICAL INTERVENTION, INC. 951 CALLE AMANECER San Clemente, CA 92672 |
| Contact | M Calvarese,ms |
| Correspondent | M Calvarese,ms ADVANCED SURGICAL INTERVENTION, INC. 951 CALLE AMANECER San Clemente, CA 92672 |
| Product Code | FAJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-11 |
| Decision Date | 1989-10-24 |