Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode
FDA 510(k) K151976 · Omnitech Systems, Inc.
510(k) numberK151976
Submission
- Device name
- Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode
- Applicant
- Omnitech Systems, Inc.
Valparaiso, IN, US - Received
- July 16, 2015
- Decision date
- June 27, 2016
- 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
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| K964365 | Resectoscope Cutting Loop ElectrodeFAS · Traditional | 04/22/1997SE |
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Questions and answers
When was Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode cleared by the FDA?
Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode (K151976) received a 510(k) decision of Substantially Equivalent on June 27, 2016, 347 days after the submission was received.
What is the product code of K151976?
The FDA product code is FAS – Electrode, Electrosurgical, Active, Urological, a Class II (moderate risk) device regulated under 21 CFR 876.4300.