XUES-41 Endoscopic Electrosurgical Unit
FDA 510(k) K030194 · The Olympus Optical Co.
510(k) numberK030194
Submission
- Device name
- XUES-41 Endoscopic Electrosurgical Unit
- Applicant
- The Olympus Optical Co.
Melville, NY, US - Received
- January 21, 2003
- Decision date
- March 24, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- KNS – Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4300
- Specialty
- Gastroenterology, Urology
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| K262460 | Rezum SystemKNS · Traditional | Boston Scientific | 09/03/2026SE |
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| K252388 | Vanquish Water Vapor Ablation DeviceKNS · Traditional | Francis Medical, Inc. | 11/26/2025SE |
| K252889 | Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)KNS · Traditional | Olympus Medical Systems Corporation | 11/25/2025SE |
| K250945 | Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use…KNS · Traditional | Olympus Medical Systems Corp. | 10/17/2025SE |
| K250351 | Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife…KNS · Traditional | Olympus Medical Systems Corporation | 10/10/2025SE |
| K251104 | SureTome SW Sphincterotome with DomeTipKNS · Traditional | Wilson-Cook Medical | 09/29/2025SE |
| K251226 | Aqua Medical RF Vapor Ablation SystemKNS · Traditional | Aqua Medical, Inc. | 08/08/2025SE |
| K250584 | Rezum SystemKNS · Traditional | Boston Scientific Corporation | 06/11/2025SE |
| K242774 | SpydrBlade Flex Instrument (PRD-RG1-001)KNS · Traditional | Creo Medical, Ltd. | 06/06/2025SE |
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| K031648 | Visera Rhino-Laryngovideoscope Olympus Enf Type VEOB · Traditional | 07/24/2003SE |
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| K021962 | Olympus Ultrasonic Surgical SystemLFL · Traditional | 02/12/2003SE |
| K021852 | Olympus PSD-20 Electrosurgical System & Its Associated AccessoriesGEI · Traditional | 02/11/2003SE |
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Questions and answers
When was XUES-41 Endoscopic Electrosurgical Unit cleared by the FDA?
XUES-41 Endoscopic Electrosurgical Unit (K030194) received a 510(k) decision of Substantially Equivalent on March 24, 2003, 62 days after the submission was received.
What is the product code of K030194?
The FDA product code is KNS – Unit, Electrosurgical, Endoscopic (With Or Without Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.4300.