Submission Details
| 510(k) Number | K203177 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 26, 2020 |
| Decision Date | January 02, 2022 |
| Days to Decision | 433 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
Sterisystem Dry-Base Instrument Tray
Jan 2022
Decision
433d
Days
Class 2
Risk
About This 510(k) Submission
K203177 is an FDA 510(k) clearance for the Sterisystem Dry-Base Instrument Tray, a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II — Special Controls, product code KCT), submitted by O&M Halyard, Inc. (Alpharetta, US). The FDA issued a Cleared decision on January 2, 2022, 433 days after receiving the submission on October 26, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.
Device Classification
| Product Code | KCT — Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.6850 |
Manufacturer
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