Submission Details
| 510(k) Number | K243581 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 14, 2024 |
| Decision Date | April 04, 2025 |
| Days to Decision | 141 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)
Apr 2025
Decision
141d
Days
Class 2
Risk
About This 510(k) Submission
K243581 is an FDA 510(k) clearance for the K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC), a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by Terumo Europe N.V. (Leuven, BE). The FDA issued a Cleared decision on April 4, 2025, 141 days after receiving the submission on November 14, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.
Device Classification
| Product Code | FMI — Needle, Hypodermic, Single Lumen |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.5570 |
Manufacturer
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