Submission Details
| 510(k) Number | K243309 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 21, 2024 |
| Decision Date | May 29, 2025 |
| Days to Decision | 220 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Special
27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)
May 2025
Decision
220d
Days
Class 2
Risk
About This 510(k) Submission
K243309 is an FDA 510(k) clearance for the 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT), 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 May 29, 2025, 220 days after receiving the submission on October 21, 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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