Softtouch II Lancet Device
FDA 510(k) K931258 · Boehringer Mannheim Corp.
Submission
- Device name
- Softtouch II Lancet Device
- Applicant
- Boehringer Mannheim Corp.
Indianapolis, IN, US - Received
- March 12, 1993
- Decision date
- February 10, 1994
- 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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Questions and answers
When was Softtouch II Lancet Device cleared by the FDA?
Softtouch II Lancet Device (K931258) received a 510(k) decision of Substantially Equivalent on February 10, 1994, 335 days after the submission was received.
What is the product code of K931258?
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.