Sharpsaway II Locking Disposable Cup
FDA 510(k) K041153 · Arrow Intl., Inc.
510(k) numberK041153
Submission
- Device name
- Sharpsaway II Locking Disposable Cup
- Applicant
- Arrow Intl., Inc.
Reading, PA, US - Received
- May 3, 2004
- Decision date
- July 12, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FMI – Needle, Hypodermic, Single Lumen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5570
- Specialty
- General Hospital
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Questions and answers
When was Sharpsaway II Locking Disposable Cup cleared by the FDA?
Sharpsaway II Locking Disposable Cup (K041153) received a 510(k) decision of Substantially Equivalent on July 12, 2004, 70 days after the submission was received.
What is the product code of K041153?
The FDA product code is FMI – Needle, Hypodermic, Single Lumen, a Class II (moderate risk) device regulated under 21 CFR 880.5570.