Submission Details
| 510(k) Number | K223854 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 23, 2022 |
| Decision Date | June 30, 2023 |
| Days to Decision | 189 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
Unistik? ShieldLock, Unistik VacuFlip
Jun 2023
Decision
189d
Days
Class 2
Risk
About This 510(k) Submission
K223854 is an FDA 510(k) clearance for the Unistik? ShieldLock, Unistik VacuFlip, a Tubes, Vials, Systems, Serum Separators, Blood Collection (Class II — Special Controls, product code JKA), submitted by Owen Mumford, Ltd. (Woodstock, GB). The FDA issued a Cleared decision on June 30, 2023, 189 days after receiving the submission on December 23, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 862.1675.
Device Classification
| Product Code | JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1675 |
Manufacturer
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