Balloon Electrosurgical Probes and Devices
FDA 510(k) K943014 · Ximed Medical Systems
510(k) numberK943014
Submission
- Device name
- Balloon Electrosurgical Probes and Devices
- Applicant
- Ximed Medical Systems
San Jose, CA, US - Received
- June 24, 1994
- Decision date
- March 11, 1996
- 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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| K946377 | Electroprobe Single Use Electrosurgical ProbesGEI · Traditional | 03/24/1995SE |
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| K922523 | Bipolar Electrosurgical Probes & InstrumentsGEI · Traditional | 09/23/1992SE |
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| K900463 | Laser Delivery Systems, Fiberoptics & Contact TipsGEX · Traditional | 03/22/1990SE |
| K892933 | Infralase-Laserguide Delivery SystemGEX · Traditional | 06/22/1989SE |
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Questions and answers
When was Balloon Electrosurgical Probes and Devices cleared by the FDA?
Balloon Electrosurgical Probes and Devices (K943014) received a 510(k) decision of Substantially Equivalent on March 11, 1996, 626 days after the submission was received.
What is the product code of K943014?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.