Instrument tray, for semi-rigid ureteroscope
FDA 510(k) K203492 · Olympus Winter & Ibe GmbH
510(k) numberK203492
Submission
- Device name
- Instrument tray, for semi-rigid ureteroscope
- Applicant
- Olympus Winter & Ibe GmbH
Hamburg, DE - Received
- November 19, 2020
- Decision date
- September 15, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KCT – Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6850
- Specialty
- General Hospital
Other 510(k)s with product code KCT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253988 | LiteSet TraysKCT · Traditional | Nobel Biocare AB | 09/08/2026SE |
| K261935 | Surgical and Prosthetic TraysKCT · Traditional | Dentsply Sirona, Inc. | 09/04/2026SE |
| K253187 | SteriBest® Sterilization Tray SystemKCT · Traditional | Mastel Surgical | 06/18/2026SE |
| K260726 | Straumann® ProClean Cassette (041.800 ; 041.801)KCT · Traditional | Institut Straumann AG | 06/03/2026SE |
| K252854 | SteriTite Container System with MediTray ProductsKCT · Traditional | Case Medical, Inc. | 06/03/2026SE |
| K253791 | PUREVUE Quick Connect Cannula System Tray; PUREVUE Quick Connect Cannula System LidKCT · Traditional | DePuy Mitek, Inc. | 02/26/2026SE |
| K251614 | Stainless Steel Surgical KitsKCT · Traditional | Dentsply Sirona, Inc. | 02/06/2026SE |
| K251756 | Sterilization TraysKCT · Traditional | Paragon Implant Mfg., LLC | 11/14/2025SE |
| K251300 | Plastic Surgical KitsKCT · Traditional | Dentsply Sirona, Inc. | 07/22/2025SE |
| K243425 | Guided DAS Surgical KitKCT · Traditional | Talladium España, SL | 07/22/2025SE |
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| K221522 | HF-cables (resusable)GEI · Traditional | 01/19/2023SE |
| K223183 | Light-Guide CablesHBI · Traditional | 01/13/2023SE |
| K213207 | Sheath, Stopcock AccessoryHIH · Traditional | 12/22/2021SE |
| K210651 | Resection Electrodes with HF cableFAS · Traditional | 08/03/2021SE |
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Questions and answers
When was Instrument tray, for semi-rigid ureteroscope cleared by the FDA?
Instrument tray, for semi-rigid ureteroscope (K203492) received a 510(k) decision of Substantially Equivalent on September 15, 2021, 300 days after the submission was received.
What is the product code of K203492?
The FDA product code is KCT – Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, a Class II (moderate risk) device regulated under 21 CFR 880.6850.