The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Optablate Rf Generator, Optablate Probes, Optablate Microinfuser Infusion Device.
| Device ID | K221074 |
| 510k Number | K221074 |
| Device Name: | OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Stryker Corporation 1941 Stryker Way Portage, MI 49002 |
| Contact | Bruce Backlund |
| Correspondent | Bruce Backlund Stryker Corporation 1941 Stryker Way Portage, MI 49002 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-12 |
| Decision Date | 2022-09-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327547610 | K221074 | 000 |
| 07613327524505 | K221074 | 000 |
| 07613327524482 | K221074 | 000 |
| 07613327524475 | K221074 | 000 |
| 07613327524512 | K221074 | 000 |
| 07613327524499 | K221074 | 000 |