Safety Biopsy Needle System
FDA 510(k) K140137 · Pfm Medical, Inc.
510(k) numberK140137
Submission
- Device name
- Safety Biopsy Needle System
- Applicant
- Pfm Medical, Inc.
Carlsbad, CA, US - Received
- January 22, 2014
- Decision date
- March 25, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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 |
More from Cook Ireland, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K242763 | JetCan® Pro Safety Huber NeedleFPA · Traditional | 05/02/2025SE |
| K241278 | ASEPT® Glide Peritoneal Drainage SystemPNG · Traditional | 01/14/2025SE |
| K221779 | ASEPT Peritoneal Drainage SystemPNG · Traditional | 05/02/2023SESK |
| K213666 | NuCath Wedge Pressure CatheterDQO · Traditional | 10/06/2022SE |
| K201137 | Asept Surgical Face MaskFXX · Abbreviated | 08/19/2020SE |
| K192802 | primeMidline CathetersPND · Special | 10/28/2019SE |
| K173114 | primeMidline CathetersPND · Traditional | 03/07/2018SE |
| K122402 | LPP (Low Profile Port)LJT · Traditional | 07/16/2013SE |
| K113354 | Veta Peritoneal Dialysis CatheterFJS · Traditional | 03/13/2012SESK |
| K110914 | Triple Lumen PFM PiccLJS · Traditional | 09/21/2011SE |
Questions and answers
When was Safety Biopsy Needle System cleared by the FDA?
Safety Biopsy Needle System (K140137) received a 510(k) decision of Substantially Equivalent on March 25, 2014, 62 days after the submission was received.
What is the product code of K140137?
The FDA product code is FCG – Biopsy Needle, a Class II (moderate risk) device regulated under 21 CFR 876.1075.