K231734 is an FDA 510(k) clearance for the STERiJECT Low Dead Space, STERiJECT The Invisible Needle. This device is classified as a Low Dead Space Needle, Single Lumen, Hypodermic (Class II - Special Controls, product code QNS).
Submitted by Tsk Laboratory International Japan KK (Tochigi-Shi, JP). The FDA issued a Cleared decision on March 8, 2024, 268 days after receiving the submission on June 14, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570. A Low Dead Space Single Lumen Hypodermic Needle Is A Device Designed To Reduce Medication Waste. The Device Consists Of A Metal Tube That Is Sharpened At One End And At The Other End Joined To Connector Designed To Mate With A Piston Syringe. It May Or May Not Have Needle Safety Features. The Device Can Be Used By Health Care Professions Or For Self-injection By The Patient..
| 510(k) Number | K231734 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 14, 2023 |
| Decision Date | March 08, 2024 |
| Days to Decision | 268 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | QNS - Low Dead Space Needle, Single Lumen, Hypodermic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5570 |
| Definition | A Low Dead Space Single Lumen Hypodermic Needle Is A Device Designed To Reduce Medication Waste. The Device Consists Of A Metal Tube That Is Sharpened At One End And At The Other End Joined To Connector Designed To Mate With A Piston Syringe. It May Or May Not Have Needle Safety Features. The Device Can Be Used By Health Care Professions Or For Self-injection By The Patient. |