The following data is part of a premarket notification filed by Advanced Surgical Intervention, Inc. with the FDA for Asi Cystolase Laser Cystoscope.
| Device ID | K930361 |
| 510k Number | K930361 |
| Device Name: | ASI CYSTOLASE LASER CYSTOSCOPE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ADVANCED SURGICAL INTERVENTION, INC. 951 CALLE AMANECER San Clemente, CA 92672 |
| Contact | Jay Lenker |
| Correspondent | Jay Lenker ADVANCED SURGICAL INTERVENTION, INC. 951 CALLE AMANECER San Clemente, CA 92672 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-26 |
| Decision Date | 1993-04-29 |