The following data is part of a premarket notification filed by Trimedyne, Inc. with the FDA for Omnitip Side Firing Switchable Tip With Suction/irrigation, Model 20371-hp.
| Device ID | K992230 |
| 510k Number | K992230 |
| Device Name: | OMNITIP SIDE FIRING SWITCHABLE TIP WITH SUCTION/IRRIGATION, MODEL 20371-HP |
| Classification | Powered Laser Surgical Instrument |
| Applicant | TRIMEDYNE, INC. 2801 BARRANCA RD. P.O. BOX 57001 Irvine, CA 92619 -7001 |
| Contact | Susan H Gamble |
| Correspondent | Susan H Gamble TRIMEDYNE, INC. 2801 BARRANCA RD. P.O. BOX 57001 Irvine, CA 92619 -7001 |
| Product Code | GEX |
| Subsequent Product Code | GBX |
| Subsequent Product Code | GCX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-02 |
| Decision Date | 1999-07-12 |
| Summary: | summary |