Gyrus Acmi Flexible Endoscope Storage-Sterilization Trays
FDA 510(k) K092682 · Gyrus Acmi, Inc.
510(k) numberK092682
Submission
- Device name
- Gyrus Acmi Flexible Endoscope Storage-Sterilization Trays
- Applicant
- Gyrus Acmi, Inc.
Southborough, MA, US - Received
- September 1, 2009
- Decision date
- December 11, 2009
- 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
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|---|---|---|---|
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| K260726 | Straumann® ProClean Cassette (041.800 ; 041.801)KCT · Traditional | Institut Straumann AG | 06/03/2026SE |
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| 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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Questions and answers
When was Gyrus Acmi Flexible Endoscope Storage-Sterilization Trays cleared by the FDA?
Gyrus Acmi Flexible Endoscope Storage-Sterilization Trays (K092682) received a 510(k) decision of Substantially Equivalent on December 11, 2009, 101 days after the submission was received.
What is the product code of K092682?
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.