Symbiosis Monopolar Electrosurgical Roller Electrodes
FDA 510(k) K955119 · Symbiosis Corp.
510(k) numberK955119
Submission
- Device name
- Symbiosis Monopolar Electrosurgical Roller Electrodes
- Applicant
- Symbiosis Corp.
Miami, FL, US - Received
- November 9, 1995
- Decision date
- January 18, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HIH – Hysteroscope (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1690
- Specialty
- Obstetrics/Gynecology
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| K243382 | RZ Resectoscope SystemHIH · Traditional | Rz Medizintechnik GmbH | 06/03/2025SE |
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| K241987 | Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)HIH · Special | Guangzhou Red Pine Medical Instrument Co., Ltd. | 08/02/2024SE |
More from Guangzhou Red Pine Medical Instrument Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K941426 | Symbiosis Reusable Monopolar Electrosurgical ProbeGEI · Traditional | 06/22/1994SE |
| 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 Monopolar Electrosurgical Roller Electrodes cleared by the FDA?
Symbiosis Monopolar Electrosurgical Roller Electrodes (K955119) received a 510(k) decision of Substantially Equivalent on January 18, 1996, 70 days after the submission was received.
What is the product code of K955119?
The FDA product code is HIH – Hysteroscope (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1690.