OneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance and Assure Lance Plus, Capiject Safety Lancet, Heel Lancet Newborn, Heel Lancet Preemie— 510(k) K222084
Substantially EquivalentAsahi Polyslider Co., Ltd.
FDA 510(k) clearance K222084 for OneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance and Assure Lance Plus, Capiject Safety Lancet, Heel Lancet Newborn, Heel Lancet Preemie, Substantially Equivalent on 2022-11-02. Applicant: Asahi Polyslider Co., Ltd..
Clearance details
- Applicant
- Asahi Polyslider Co., Ltd.
- Product code
- Code FMK
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Maniwa, JP
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.