Deltacut (Apparatus and Cannula)
FDA 510(k) K063233 · PAJUNK GmbH Medizintechnologie
510(k) numberK063233
Submission
- Device name
- Deltacut (Apparatus and Cannula)
- Applicant
- PAJUNK GmbH Medizintechnologie
Geisingen, DE - Received
- October 25, 2006
- Decision date
- April 30, 2007
- 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 Deltacut (Apparatus and Cannula) cleared by the FDA?
Deltacut (Apparatus and Cannula) (K063233) received a 510(k) decision of Substantially Equivalent on April 30, 2007, 187 days after the submission was received.
What is the product code of K063233?
The FDA product code is KNW – Instrument, Biopsy, a Class II (moderate risk) device regulated under 21 CFR 876.1075.