Electroprobe Single-Use Surgical Probe
FDA 510(k) K903812 · Ximed Medical Systems
510(k) numberK903812
Submission
- Device name
- Electroprobe Single-Use Surgical Probe
- Applicant
- Ximed Medical Systems
Santa Clara, CA, US - Received
- August 20, 1990
- Decision date
- September 20, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K943014 | Balloon Electrosurgical Probes and DevicesGEI · Traditional | 03/11/1996SE |
| K946377 | Electroprobe Single Use Electrosurgical ProbesGEI · Traditional | 03/24/1995SE |
| K933757 | Hand-Held Irrigation PumpBTA · Traditional | 08/26/1994SE |
| K933458 | Surgical TrocarsGCJ · Traditional | 05/05/1994SE |
| K922714 | Universal Irrigation & Suction Tubing SetJOL · Traditional | 08/03/1993SE |
| K922523 | Bipolar Electrosurgical Probes & InstrumentsGEI · Traditional | 09/23/1992SE |
| K900463 | Laser Delivery Systems, Fiberoptics & Contact TipsGEX · Traditional | 03/22/1990SE |
| K892933 | Infralase-Laserguide Delivery SystemGEX · Traditional | 06/22/1989SE |
| K890775 | Infralase - Laserguide Delivery SystemGEX · Traditional | 04/21/1989SE |
| K891126 | Microlase CO2 Laser MicromanipulatorGEX · Traditional | 03/17/1989SE |
Questions and answers
When was Electroprobe Single-Use Surgical Probe cleared by the FDA?
Electroprobe Single-Use Surgical Probe (K903812) received a 510(k) decision of Substantially Equivalent on September 20, 1990, 31 days after the submission was received.
What is the product code of K903812?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.