Bipolar Electrosurgical Probes and Instruments
FDA 510(k) K945995 · Ximed/Prosure/Injectx
510(k) numberK945995
Submission
- Device name
- Bipolar Electrosurgical Probes and Instruments
- Applicant
- Ximed/Prosure/Injectx
San Jose, CA, US - Received
- October 6, 1994
- Decision date
- January 31, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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).
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| K002269 | Electrosurgical Probes and Devices-GeltxGEI · Traditional | 01/04/2001SE |
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| K983765 | Injection Needle Probe/Device-TunisFBK · Traditional | 12/11/1998SE |
| K983200 | Injection/Aspiration Needles Probes/Devices-Tpi/Tpi FlexGAA · Traditional | 12/11/1998SE |
| K981256 | Isolated Saline Electrodes/Probes/Devices-SalinetrodeFAS · Traditional | 05/12/1998SE |
| K974484 | Isolated Electrosurgical Probes and Devices-SalinetrodeGEI · Traditional | 02/10/1998SE |
| K974637 | Electrodes/Probes/DevicesFAS · Traditional | 01/07/1998SE |
| K962593 | Electrosurgical Probes & DevicesGEI · Traditional | 11/12/1996SE |
Questions and answers
When was Bipolar Electrosurgical Probes and Instruments cleared by the FDA?
Bipolar Electrosurgical Probes and Instruments (K945995) received a 510(k) decision of Substantially Equivalent on January 31, 1995, 117 days after the submission was received.
What is the product code of K945995?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.