Omnitech Resectoscope Roller Electrode
FDA 510(k) K981463 · Omnitech Systems, Inc.
510(k) numberK981463
Submission
- Device name
- Omnitech Resectoscope Roller Electrode
- Applicant
- Omnitech Systems, Inc.
Valparaiso, IN, US - Received
- April 23, 1998
- Decision date
- July 17, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KNF – Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4160
- Specialty
- Obstetrics/Gynecology
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| K121343 | Modulap LoopKNF · Traditional | Atc Technologies, Inc. | 06/14/2013SE |
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More from Integra LifeSciences Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K151976 | Omnitech HF Resection Electrodes, Omnitech HF Vaporization ElectrodeFAS · Traditional | 06/27/2016SE |
| K050454 | Omnitech Fulgurating ElectrodeFAS · Traditional | 05/27/2005SE |
| K981464 | Omnitech Resectoscope Cutting Loop ElectrodeKNF · Traditional | 07/10/1998SE |
| K964365 | Resectoscope Cutting Loop ElectrodeFAS · Traditional | 04/22/1997SE |
| K965093 | Omnitech Resectoscope Roller ElectrodeFAS · Traditional | 03/19/1997SE |
Questions and answers
When was Omnitech Resectoscope Roller Electrode cleared by the FDA?
Omnitech Resectoscope Roller Electrode (K981463) received a 510(k) decision of Substantially Equivalent on July 17, 1998, 85 days after the submission was received.
What is the product code of K981463?
The FDA product code is KNF – Coagulator-Cutter, Endoscopic, Unipolar (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.4160.