Resection Electrodes with HF cable
FDA 510(k) K171965 · Olympus Winter & Ibe GmbH
510(k) numberK171965
Submission
- Device name
- Resection Electrodes with HF cable
- Applicant
- Olympus Winter & Ibe GmbH
Hamburg, DE - Received
- June 30, 2017
- Decision date
- September 28, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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| K223183 | Light-Guide CablesHBI · Traditional | 01/13/2023SE |
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| K210651 | Resection Electrodes with HF cableFAS · Traditional | 08/03/2021SE |
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Questions and answers
When was Resection Electrodes with HF cable cleared by the FDA?
Resection Electrodes with HF cable (K171965) received a 510(k) decision of Substantially Equivalent on September 28, 2017, 90 days after the submission was received.
What is the product code of K171965?
The FDA product code is FAS – Electrode, Electrosurgical, Active, Urological, a Class II (moderate risk) device regulated under 21 CFR 876.4300.