Gripper Micro Blunt Cannula, Non-Coring Safety Needle (Gripper Micro Needle) Model: 21-3253-24, 21-3258-24, 21-3262-24,
FDA 510(k) K101180 · Smiths Medical MD, Inc.
510(k) numberK101180
Submission
- Device name
- Gripper Micro Blunt Cannula, Non-Coring Safety Needle (Gripper Micro Needle) Model: 21-3253-24, 21-3258-24, 21-3262-24,
- Applicant
- Smiths Medical MD, Inc.
St. Paul, MN, US - Received
- April 27, 2010
- Decision date
- August 3, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FPA – Set, Administration, Intravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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Questions and answers
When was Gripper Micro Blunt Cannula, Non-Coring Safety Needle (Gripper Micro Needle) Model: 21-3253-24, 21-3258-24, 21-3262-24, cleared by the FDA?
Gripper Micro Blunt Cannula, Non-Coring Safety Needle (Gripper Micro Needle) Model: 21-3253-24, 21-3258-24, 21-3262-24, (K101180) received a 510(k) decision of Substantially Equivalent on August 3, 2010, 98 days after the submission was received.
What is the product code of K101180?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.