Surelite and Surelite XL Blood Lancet
FDA 510(k) K902416 · Gainor Medical Europe, Ltd.
Submission
- Device name
- Surelite and Surelite XL Blood Lancet
- Applicant
- Gainor Medical Europe, Ltd.
Mcdonough, GA, US - Received
- May 31, 1990
- Decision date
- August 1, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FMK – Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4850
- Specialty
- General, Plastic Surgery
A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base (including an integral sharps injury prevention feature) that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable and incapable…
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Questions and answers
When was Surelite and Surelite XL Blood Lancet cleared by the FDA?
Surelite and Surelite XL Blood Lancet (K902416) received a 510(k) decision of Substantially Equivalent on August 1, 1990, 62 days after the submission was received.
What is the product code of K902416?
The FDA product code is FMK – Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature, a Class II (moderate risk) device regulated under 21 CFR 878.4850.