BNX Delivery System Pre-Loaded with 19, 22 and 25 Gauge Needle, 19, 22 or 25 Gauge Needles (Individually Sterile-Packed,
FDA 510(k) K133008 · Beacon Endoscopic
510(k) numberK133008
Submission
- Device name
- BNX Delivery System Pre-Loaded with 19, 22 and 25 Gauge Needle, 19, 22 or 25 Gauge Needles (Individually Sterile-Packed,
- Applicant
- Beacon Endoscopic
Auburndale, MA, US - Received
- September 25, 2013
- Decision date
- November 20, 2013
- 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
Other 510(k)s with product code FCG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252646 | Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)FCG · Traditional | Olympus Medical Systems Corp. | 10/24/2025SE |
| K250994 | ClearTip FNA and FNB TypesFCG · Traditional | Finemedix Co., Ltd. | 08/21/2025SE |
| K241209 | EchoTip AcuCore EUS Biopsy Needle (ECHO-BX-19)FCG · Traditional | Cook Ireland, Ltd. | 07/29/2024SE |
| K231422 | Precision GIFCG · Traditional | Limaca Medical, Ltd. | 08/28/2023SE |
| 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 |
Questions and answers
When was BNX Delivery System Pre-Loaded with 19, 22 and 25 Gauge Needle, 19, 22 or 25 Gauge Needles (Individually Sterile-Packed, cleared by the FDA?
BNX Delivery System Pre-Loaded with 19, 22 and 25 Gauge Needle, 19, 22 or 25 Gauge Needles (Individually Sterile-Packed, (K133008) received a 510(k) decision of Substantially Equivalent on November 20, 2013, 56 days after the submission was received.
What is the product code of K133008?
The FDA product code is FCG – Biopsy Needle, a Class II (moderate risk) device regulated under 21 CFR 876.1075.