Easy Core Biopsy System
FDA 510(k) K040893 · Boston Scientific Corp
510(k) numberK040893
Submission
- Device name
- Easy Core Biopsy System
- Applicant
- Boston Scientific Corp
Natick,, MA, US - Received
- April 6, 2004
- Decision date
- May 6, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FCG – Biopsy Needle
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1075
- Specialty
- Gastroenterology, Urology
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| K212423 | EndoDrill® Model XFCG · Traditional | Bibbinstruments AB | 03/29/2023SE |
| K212822 | Disposable Coaxial Biopsy NeedleFCG · Traditional | Suzhou Leapmed Healthcare Corporation | 07/06/2022SE |
| K212819 | Disposable Biopsy Refill NeedleFCG · Traditional | Suzhou Leapmed Healthcare Corporation | 07/06/2022SE |
| K210476 | EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle…FCG · Traditional | Cook Ireland, Ltd. | 05/20/2021SE |
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Questions and answers
When was Easy Core Biopsy System cleared by the FDA?
Easy Core Biopsy System (K040893) received a 510(k) decision of Substantially Equivalent on May 6, 2004, 30 days after the submission was received.
What is the product code of K040893?
The FDA product code is FCG – Biopsy Needle, a Class II (moderate risk) device regulated under 21 CFR 876.1075.