K2M Fenestrated Tap System
FDA 510(k) K152872 · K2m
510(k) numberK152872
Submission
- Device name
- K2M Fenestrated Tap System
- Applicant
- K2m
Leesburg, VA, US - Received
- September 30, 2015
- Decision date
- January 5, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KNW – Instrument, Biopsy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1075
- Specialty
- Gastroenterology, Urology
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Questions and answers
When was K2M Fenestrated Tap System cleared by the FDA?
K2M Fenestrated Tap System (K152872) received a 510(k) decision of Substantially Equivalent on January 5, 2016, 97 days after the submission was received.
What is the product code of K152872?
The FDA product code is KNW – Instrument, Biopsy, a Class II (moderate risk) device regulated under 21 CFR 876.1075.