Microgyn Resection Loop, Coagulating Electrode, Ciss Sheath Electrode, Loop Electrode Kit and Coagulating Electrode Kit
FDA 510(k) K962653 · Microgyn Corp.
510(k) numberK962653
Submission
- Device name
- Microgyn Resection Loop, Coagulating Electrode, Ciss Sheath Electrode, Loop Electrode Kit and Coagulating Electrode Kit
- Applicant
- Microgyn Corp.
Taunton, MA, US - Received
- July 8, 1996
- Decision date
- February 4, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FAS – Electrode, Electrosurgical, Active, Urological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4300
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FAS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251403 | Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr…FAS · Traditional | Dornier Medtech America Inc (Dmta) | 12/05/2025SE |
| K250522 | Multi4 SystemFAS · Traditional | Multi4 Medical AB | 06/27/2025SE |
| K240504 | PLASMA EDGE SystemFAS · Special | Lamidey Noury Medical | 06/12/2024SE |
| K213135 | Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor…FAS · Special | Chirurgie Innovation | 03/02/2022SE |
| K210651 | Resection Electrodes with HF cableFAS · Traditional | Olympus Winter & Ibe GmbH | 08/03/2021SE |
| K210394 | Electrosurgical accessoryFAS · Traditional | Dornier Medtech America, Inc. | 05/19/2021SE |
| K171965 | Resection Electrodes with HF cableFAS · Traditional | Olympus Winter & Ibe GmbH | 09/28/2017SE |
| K163090 | Plasma Edge SystemFAS · Traditional | Chirurgie Innovation | 05/23/2017SE |
| K151976 | Omnitech HF Resection Electrodes, Omnitech HF Vaporization ElectrodeFAS · Traditional | Omnitech Systems, Inc. | 06/27/2016SE |
| K152092 | Resection ElectrodesFAS · Traditional | Olympus Winter & Ibe GmbH | 10/26/2015SE |
Questions and answers
When was Microgyn Resection Loop, Coagulating Electrode, Ciss Sheath Electrode, Loop Electrode Kit and Coagulating Electrode Kit cleared by the FDA?
Microgyn Resection Loop, Coagulating Electrode, Ciss Sheath Electrode, Loop Electrode Kit and Coagulating Electrode Kit (K962653) received a 510(k) decision of Substantially Equivalent on February 4, 1997, 211 days after the submission was received.
What is the product code of K962653?
The FDA product code is FAS – Electrode, Electrosurgical, Active, Urological, a Class II (moderate risk) device regulated under 21 CFR 876.4300.