K222385 is an FDA 510(k) clearance for the Bifurcated Needle. This device is classified as a Allergen And Vaccine Delivery Needles (Class II - Special Controls, product code SCL).
Submitted by Anhui Tiankang Medical Technology Co., Ltd. (Tianchang, CN). The FDA issued a Cleared decision on December 6, 2022, 120 days after receiving the submission on August 8, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570. An Allergen Delivery Needle Is A Device Intended To Percutaneously Deliver Diagnostic Allergenic Extracts For Use In Allergy Skin Tests Also Referred To As Skin Prick Tests Or Intradermal Allergy Tests..
| 510(k) Number | K222385 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 08, 2022 |
| Decision Date | December 06, 2022 |
| Days to Decision | 120 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | SCL - Allergen And Vaccine Delivery Needles |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5570 |
| Definition | An Allergen Delivery Needle Is A Device Intended To Percutaneously Deliver Diagnostic Allergenic Extracts For Use In Allergy Skin Tests Also Referred To As Skin Prick Tests Or Intradermal Allergy Tests. |