Easy Core Detachable Biopsy System
FDA 510(k) K051361 · Boston Scientific Corp
510(k) numberK051361
Submission
- Device name
- Easy Core Detachable Biopsy System
- Applicant
- Boston Scientific Corp
Marlboro, MA, US - Received
- May 25, 2005
- Decision date
- June 16, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| K262571 | EnCor EnCompass Breast Biopsy and Tissue Removal SystemKNW · Special | Bard Peripheral Vascular, Inc. | 08/14/2026SE |
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Questions and answers
When was Easy Core Detachable Biopsy System cleared by the FDA?
Easy Core Detachable Biopsy System (K051361) received a 510(k) decision of Substantially Equivalent on June 16, 2005, 22 days after the submission was received.
What is the product code of K051361?
The FDA product code is KNW – Instrument, Biopsy, a Class II (moderate risk) device regulated under 21 CFR 876.1075.