Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets— 510(k) K221613
Substantially EquivalentOwen Mumford, Ltd.
FDA 510(k) clearance K221613 for Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets, Substantially Equivalent on 2022-10-03. Applicant: Owen Mumford, Ltd.. Device class: 2.
Clearance details
- Applicant
- Owen Mumford, Ltd.
- Product code
- Code QRL
- Device class
- Class 2
- Regulation
- 21 CFR 878.4850
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Woodstock, GB
Recent devices under product code QRL
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- K222303 — Unistik® Pro
- K222111 — Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G
Adverse events under product code QRL
product code QRL- Other
- 1
- Total
- 1
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.