The Keymed Fiberscope Sterilization Case
FDA 510(k) K860528 · Keymed, Inc.
510(k) numberK860528
Submission
- Device name
- The Keymed Fiberscope Sterilization Case
- Applicant
- Keymed, Inc.
Essex Ss2 5qh England, GB - Received
- February 11, 1986
- Decision date
- July 15, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
More from Talladium España, SL
| 510(k) | Device | Decision |
|---|---|---|
| K100803 | Olympus Flushing Pump Ofp Model: OFP-1FEQ · Special | 04/22/2010SE |
| K921179 | Olympus-Keymed Disinfectant Fume Extractor DFE-20FEB · Traditional | 03/29/1993SE |
| K881004 | Olympus-Keymed Endoscopic CO2 Regulator, Model EcrFCX · Traditional | 05/12/1988SE |
| K861821 | Keymed Fiberscope Auto DisinfectorNVE · Traditional | 02/12/1987SE |
| K864801 | The Keymed Hi-Light 250 Light SourceGCT · Traditional | 12/24/1986SE |
| K862000 | Keymed Flexible Esophageal DilatorsKNQ · Traditional | 08/12/1986SE |
| K861147 | UCS-2, Ultrasonic Cleaning SolutionFLG · Traditional | 06/23/1986SE |
| K860704 | The Keymed Sigmoidoscope Disinfection StandNZA · Traditional | 06/17/1986SE |
| K851149 | Key Med Transendoscopic Vascular Detector TVD-1JAF · Traditional | 11/26/1985SE |
| K854304 | Keymed Office CouchFPO · Traditional | 11/12/1985SE |
Questions and answers
When was The Keymed Fiberscope Sterilization Case cleared by the FDA?
The Keymed Fiberscope Sterilization Case (K860528) received a 510(k) decision of Substantially Equivalent on July 15, 1986, 154 days after the submission was received.
What is the product code of K860528?
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.