Bard Biopty-Cut Biopsy Needle with Spacer
FDA 510(k) K910720 · C.R. Bard, Inc.
510(k) numberK910720
Submission
- Device name
- Bard Biopty-Cut Biopsy Needle with Spacer
- Applicant
- C.R. Bard, Inc.
Covington, GA, US - Received
- February 20, 1991
- Decision date
- June 10, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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|---|---|---|---|
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| K241209 | EchoTip AcuCore EUS Biopsy Needle (ECHO-BX-19)FCG · Traditional | Cook Ireland, Ltd. | 07/29/2024SE |
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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 |
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| K251186 | Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)LDF · Special | 05/15/2025SE |
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| K230356 | Aspirex Thrombectomy SystemQEW · Traditional | 03/31/2023SE |
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Questions and answers
When was Bard Biopty-Cut Biopsy Needle with Spacer cleared by the FDA?
Bard Biopty-Cut Biopsy Needle with Spacer (K910720) received a 510(k) decision of Substantially Equivalent on June 10, 1991, 110 days after the submission was received.
What is the product code of K910720?
The FDA product code is FCG – Biopsy Needle, a Class II (moderate risk) device regulated under 21 CFR 876.1075.