The following data is part of a premarket notification filed by Gyrus Ent L.l.c. with the FDA for Hemostatix Thermal Scalpel System - #12 Blade.
| Device ID | K002021 |
| 510k Number | K002021 |
| Device Name: | HEMOSTATIX THERMAL SCALPEL SYSTEM - #12 BLADE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | GYRUS ENT L.L.C. 2925 APPLING RD. Bartlett, TN 38133 |
| Contact | Alicia Farage |
| Correspondent | Alicia Farage 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 | 2000-07-03 |
| Decision Date | 2000-08-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858736006076 | K002021 | 000 |
| 00850007350260 | K002021 | 000 |