Quick-Care Biopsy Needle
FDA 510(k) K973565 · Cook, Inc.
510(k) numberK973565
Submission
- Device name
- Quick-Care Biopsy Needle
- Applicant
- Cook, Inc.
Bloomington, IN, US - Received
- September 19, 1997
- Decision date
- November 3, 1997
- 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 Quick-Care Biopsy Needle cleared by the FDA?
Quick-Care Biopsy Needle (K973565) received a 510(k) decision of Substantially Equivalent on November 3, 1997, 45 days after the submission was received.
What is the product code of K973565?
The FDA product code is KNW – Instrument, Biopsy, a Class II (moderate risk) device regulated under 21 CFR 876.1075.