The following data is part of a premarket notification filed by Hysterx, Inc. with the FDA for Micrograsp Bipolar Coagulator, Models 90048-90057.
| Device ID | K000911 |
| 510k Number | K000911 |
| Device Name: | MICROGRASP BIPOLAR COAGULATOR, MODELS 90048-90057 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | HYSTERX, INC. 18732 SAGINAW Irvine, CA 92612 |
| Contact | Judy F Gordon |
| Correspondent | Judy F Gordon HYSTERX, INC. 18732 SAGINAW Irvine, CA 92612 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-21 |
| Decision Date | 2000-04-14 |