The following data is part of a premarket notification filed by Gyrus Ent L.l.c. with the FDA for Hemostatix, Model 2400z Thermal Scalpel System.
| Device ID | K033089 |
| 510k Number | K033089 |
| Device Name: | HEMOSTATIX, MODEL 2400Z THERMAL SCALPEL SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | GYRUS ENT L.L.C. 2925 APPLING RD. Bartlett, TN 38133 |
| Contact | Gregory Sredin |
| Correspondent | Gregory Sredin GYRUS ENT L.L.C. 2925 APPLING RD. Bartlett, TN 38133 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-29 |
| Decision Date | 2004-02-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858736006069 | K033089 | 000 |
| 00858736006052 | K033089 | 000 |
| 00858736006045 | K033089 | 000 |
| 00858736006038 | K033089 | 000 |