Unistik® ShieldLock, Unistik VacuFlip— 510(k) K223854
Substantially EquivalentOwen Mumford, Ltd.
FDA 510(k) clearance K223854 for Unistik® ShieldLock, Unistik VacuFlip, Substantially Equivalent on 2023-06-30. Applicant: Owen Mumford, Ltd.. Device class: 2.
Clearance details
- Applicant
- Owen Mumford, Ltd.
- Product code
- Product code JKA
- Device class
- Class 2
- Regulation
- 21 CFR 862.1675
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Woodstock, GB
Recent devices under product code JKA
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- K252899 — Female Culture Device; Male Culture Device; Transfer Device; Access Device
More clearances from Owen Mumford, Ltd.
view all- K231124 — Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle (30G)
- K222168 — Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie and Full-Term, Unistik Heelstik Sterile Single-Use Heel Incision Safety Lancets - MicroPreemie, Preemie, Full-Term and Toddler
- K222303 — Unistik® Pro
- K221613 — Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets
- K222111 — Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G
Adverse events under product code JKA
product code JKA- Injury
- 455
- Malfunction
- 26,686
- Other
- 4
- Total
- 27,145
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.