Biopsy Sciences, LLC Maxi-Cell Biopsy Needles
FDA 510(k) K021847 · Biopsy Sciences, LLC
510(k) numberK021847
Submission
- Device name
- Biopsy Sciences, LLC Maxi-Cell Biopsy Needles
- Applicant
- Biopsy Sciences, LLC
Yorba Linda, CA, US - Received
- June 5, 2002
- Decision date
- September 3, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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| K231267 | ClearTipFCG · Traditional | Finemedix Co., Ltd. | 06/30/2023SE |
| K230909 | EchoTip® AcuCore Ultrasound Biopsy Needle (ECHO-BX-3-22)FCG · Traditional | Cook Ireland, Ltd. | 05/30/2023SE |
| 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 |
More from Cook Ireland, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K130537 | Biopsy Sciences LLC Hydromark Breast Biopsy Site MarkerNEU · Special | 03/29/2013SE |
| K121113 | Biopsy Sciences, Inc. Hydromark Brest Biosy Site MarkerNEU · Traditional | 07/12/2012SE |
| K090501 | Biopsy Sciences Hydromark Breast Biopsy Site Marker, Models 4005-02-15-T1…NEU · Special | 03/05/2009SE |
| K083006 | Biopsy Sciences, Inc., Hydromark Breast Biopsy Site MarkerNEU · Special | 02/09/2009SE |
| K060769 | Hydromark Biopsy Site MarkerNEU · Traditional | 07/25/2006SE |
| K041331 | Biopsy Sciences, LLC, Lung Biopsy Site MarkerGDW · Traditional | 06/15/2004SE |
| K023694 | Bio-Mark Resorbable Biopsy Site Marker and Bio-Mark Permanent Biopsy Site MarkerNEU · Traditional | 03/17/2003SE |
Questions and answers
When was Biopsy Sciences, LLC Maxi-Cell Biopsy Needles cleared by the FDA?
Biopsy Sciences, LLC Maxi-Cell Biopsy Needles (K021847) received a 510(k) decision of Substantially Equivalent on September 3, 2002, 90 days after the submission was received.
What is the product code of K021847?
The FDA product code is FCG – Biopsy Needle, a Class II (moderate risk) device regulated under 21 CFR 876.1075.