OptaBlate Radiofrequency (RF) Generator System
FDA 510(k) K250327 · Stryker Instruments
510(k) numberK250327
Submission
- Device name
- OptaBlate Radiofrequency (RF) Generator System
- Applicant
- Stryker Instruments
Portage, MI, US - Received
- February 5, 2025
- Decision date
- April 15, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Other 510(k)s with product code GEI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254185 | Potenza PrimeGEI · Traditional | Jeisys Medical Incorporated | 09/11/2026SE |
| K262364 | Ellian Enigma RF DeviceGEI · Traditional | Ellian Corp | 09/02/2026SE |
| K253859 | Scarlet Pro (Scarlet Pro)GEI · Traditional | VIOL Co., Ltd. | 08/27/2026SE |
| K252535 | Inno-Switch Laparoscopic InstrumentsGEI · Traditional | Taiwan Surgical Corporation | 08/25/2026SE |
| K261179 | AlphaTriPart - Monopolar MIC InstrumentsGEI · Traditional | Gimmi GmbH | 07/22/2026SE |
| K253504 | VolnewmerGEI · Traditional | Classys, Inc. | 07/13/2026SE |
| K254056 | THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…GEI · Traditional | Olympus Medical Systems Corp. | 07/01/2026SE |
| K253484 | Lutronic GeniusGEI · Traditional | Cynosure Lutronic Technology Corporation | 06/29/2026SE |
| K251492 | Irrigation Tubing Bipolar Cord SetGEI · Traditional | New Deantronics Taiwan , Ltd. | 06/29/2026SE |
| K260636 | Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingGEI · Traditional | Stryker Sustainability Solutions | 06/18/2026SE |
More from Stryker Sustainability Solutions
| 510(k) | Device | Decision |
|---|---|---|
| K261544 | Hydro Irrigation SystemEOB · Traditional | 06/17/2026SE |
| K253679 | Hydro Irrigation SystemGWG · Traditional | 05/08/2026SE |
| K252282 | SurgiCount+ SystemPBZ · Traditional | 03/16/2026SE |
| K251971 | RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip…OLO · Traditional | 09/25/2025SE |
| K250483 | PhotonBlade 3; PhotonBlade 3 Smoke EvacuationGEI · Traditional | 09/09/2025SE |
| K250213 | OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN…GXI · Traditional | 05/15/2025SE |
| K243930 | Sonopet iQ Ultrasonic Aspirator System (5500-050-000)LFL · Traditional | 03/24/2025SE |
| K243958 | Consolidated Operating Room Equipment (CORE) 2 ConsoleOLO · Traditional | 03/21/2025SE |
| K250374 | iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round…HBE · Special | 03/11/2025SE |
| K242834 | System 9 Sterile Battery ContainerKCT · Traditional | 01/16/2025SE |
Questions and answers
When was OptaBlate Radiofrequency (RF) Generator System cleared by the FDA?
OptaBlate Radiofrequency (RF) Generator System (K250327) received a 510(k) decision of Substantially Equivalent on April 15, 2025, 69 days after the submission was received.
What is the product code of K250327?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.