Submission Details
| 510(k) Number | K240330 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 05, 2024 |
| Decision Date | August 07, 2024 |
| Days to Decision | 184 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650)
Aug 2024
Decision
184d
Days
Class 2
Risk
About This 510(k) Submission
K240330 is an FDA 510(k) clearance for the HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650), a Wrap, Sterilization (Class II — Special Controls, product code FRG), submitted by O&M Halyard, Inc. (Mechanicsville, US). The FDA issued a Cleared decision on August 7, 2024, 184 days after receiving the submission on February 5, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.
Device Classification
| Product Code | FRG — Wrap, Sterilization |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.6850 |
Manufacturer
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