Symbiosis Reusable Monopolar Electrosurgical Probe
FDA 510(k) K941426 · Symbiosis Corp.
510(k) numberK941426
Submission
- Device name
- Symbiosis Reusable Monopolar Electrosurgical Probe
- Applicant
- Symbiosis Corp.
Miami, FL, US - Received
- March 24, 1994
- Decision date
- June 22, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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).
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| 510(k) | Device | Decision |
|---|---|---|
| K955119 | Symbiosis Monopolar Electrosurgical Roller ElectrodesHIH · Traditional | 01/18/1996SE |
| K953453 | Symbiosis Monopolar Electrosurgical Roller ElectrodesFAS · Traditional | 01/17/1996SE |
| K953242 | Symbiosis Monoplar Electrosurgical ElectrodesKNF · Traditional | 10/06/1995SE |
| K952432 | Symbiosis Bipolar ForcepsGEI · Traditional | 07/05/1995SE |
| K951387 | Symbiosis Bipolar ScissorsGCJ · Traditional | 04/10/1995SE |
| K950286 | Symbiosis Bipolar ScissorsGCJ · Traditional | 02/03/1995SE |
| K946238 | Symbiosis Gastrointestinal Biopsy ForcepsFCL · Traditional | 01/20/1995SE |
| K930773 | Symbiosis Gynecological Biopsy ForcepsHFB · Traditional | 07/28/1994SE |
| K932266 | Symbiosis Dispos Gastro Biopsy Forceps W/Reuse HanKGE · Traditional | 03/15/1994SE |
| K931957 | Symbiosis Disposable Urological Biopsy ForcepsFCL · Traditional | 02/28/1994SE |
Questions and answers
When was Symbiosis Reusable Monopolar Electrosurgical Probe cleared by the FDA?
Symbiosis Reusable Monopolar Electrosurgical Probe (K941426) received a 510(k) decision of Substantially Equivalent on June 22, 1994, 90 days after the submission was received.
What is the product code of K941426?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.