NanoDrop Lancet
FDA 510(k) K223826 · Drawbridge Health, Inc.
Submission
- Device name
- NanoDrop Lancet
- Applicant
- Drawbridge Health, Inc.
Summerville, FL, US - Received
- December 21, 2022
- Decision date
- February 22, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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| K243533 | Sterilized Eol Auto Lancet; Sterilized Eol Lancet PlusFMK · Traditional | Hlb Co., Ltd. Healthcare | 01/13/2025SE |
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Questions and answers
When was NanoDrop Lancet cleared by the FDA?
NanoDrop Lancet (K223826) received a 510(k) decision of Substantially Equivalent on February 22, 2024, 428 days after the submission was received.
What is the product code of K223826?
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.