Unistik® 3, sterile single-use safety lancets +2 more— 510(k) K221126
Substantially EquivalentOwen Mumford, Ltd.
FDA 510(k) clearance K221126 for Unistik® 3, sterile single-use safety lancets +2 more, Substantially Equivalent on 2022-08-12. Applicant: Owen Mumford, Ltd.. Device class: 2.
Clearance details
- Device name as filed
- Unistik® 3, sterile single-use safety lancets; Unistik® 3 Value, sterile single-use safety lancets; Abbott SF sterile single-use safety lancets
- Applicant
- Owen Mumford, Ltd.
- Product code
- Code FMK
- 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 FMK
view allMore clearances from Owen Mumford, Ltd.
view all- K223854 — Unistik® ShieldLock, Unistik VacuFlip
- 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
Adverse events under product code FMK
product code FMK- Injury
- 133
- Malfunction
- 1,278
- Other
- 1
- Total
- 1,412
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.