Product code FCG— Gastroenterology, Urology
CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE
- Classification name
- Biopsy Needle
- Device class
- Class 2
- Regulation
- 21 CFR 876.1075
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 133
- First cleared
- Most recent
Market context for product code FCG
FDA has cleared devices under product code FCG between 1977 and 2025, filed by 80 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2025
- 2024
- 2023
- 2022
- 2021
- 2020
- 2018
- 2017
- 2016
- 2015
- 2014
- 2013
- 2011
- 2010
- 2009
Top applicants under product code FCG
Adverse events under product code FCG
product code FCG- Death
- 13
- Injury
- 576
- Malfunction
- 1,966
- Total
- 2,555
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code FCG
1–100 of 133- K252646 — Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)
- K250994 — ClearTip FNA and FNB Types
- K241209 — EchoTip AcuCore EUS Biopsy Needle (ECHO-BX-19)
- K231422 — Precision GI
- K231267 — ClearTip
- K230909 — EchoTip® AcuCore Ultrasound Biopsy Needle (ECHO-BX-3-22)
- K212423 — EndoDrill® Model X
- K212819 — Disposable Biopsy Refill Needle
- K212822 — Disposable Coaxial Biopsy Needle
- K210476 — EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial High Definition Ultrasound Needle, EchoTip ProCore Endobronchial High Definition Ultrasound Biopsy Needle
- K191472 — Biopsy Needle
- K181756 — Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle
- K180668 — Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N
- K180363 — Clear-Tip EUS-FNA
- K181994 — Single Use Aspiration Needle NA-U201H
- K180449 — Single Use Aspiration Needle NA-U200H
- K180037 — Beacon EUS Access System
- K171956 — Sterile Endoscope Biopsy Sampling Needle
- K171596 — ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle
- K160890 — Howell Biliary Introducer Needle
- K160423 — Perineologic Access Needle
- K160098 — Single Use Aspiration Needle NA-U401SX
- K160229 — Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle
- K151738 — Single Use Aspiration Needle NA-U200H
- K151895 — Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
- K151373 — Corvocet Coaxial Introducer
- K150891 — BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System
- K142688 — Echotip Procore HD Ultrasound Biopsy Needle
- K131925 — HS NOTA
- K141894 — SHARKCORE FINE NEEDLE BIOPSY SYSTEM
- K133763 — SONOTIP PRO AND PRO FLEX EBUS-TBNA NEEDLE SYSTEM
- K140137 — SAFETY BIOPSY NEEDLE SYSTEM
- K133008 — BNX DELIVERY SYSTEM PRE-LOADED WITH 19, 22 AND 25 GAUGE NEEDLE, 19, 22 OR 25 GAUGE NEEDLES (INDIVIDUALLY STERILE-PACKED,
- K103694 — TISSUE SAMPLING NEEDLE
- K103668 — BNX FINE NEEDLE ASPIRATION SYSTEM
- K100712 — RESOUND ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
- K093195 — ECHOTIP ULTRA ENDOBRONCHIAL HIGH DEFINITION ULTASOUND NEEDLE, MODEL: ECHO-HD-22-EBUS-O
- K092359 — ECHO TIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE, MODEL: ECHO-HD-19A
- K091257 — MEDI-GLOBE SONOTIP II EBUS-TBNA NEEDLE SYSTEM
- K083802 — SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01-18-025 AND GUS-01-27-025
- K083330 — ECHOTIP ULTRA ULTRASOUND NEEDLE
- K081323 — BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818
- K073399 — TARGETSCAN BIOPSY KIT, TARGETSCAN BIOPSY NEEDLE GUIDE
- K062979 — THYROSAMPLER
- K070179 — TROKABONE, TROKABONE STERNAL
- K070129 — SONOTIP II ULTRASOUND NEEDLE SYSTEM
- K051506 — MIELO-CAN, BEST-LISAS, BEN - BONE BIOPSY. FAST-CUT, COLT, SPRING-CUT, BIO-CUT - SOFT TISSUE BIOPSY
- K050135 — K-C HEMOSTATIC BIOPSY SYSTEM
- K051247 — SONOTIP II ULTRASOUND NEEDLE SYSTEM
- K050503 — SINGLE USE ASPIRATION NEEDLE NA-201SX-4022
- K050120 — EASY CORE BIOPSY SYSTEM II
- K040893 — EASY CORE BIOPSY SYSTEM
- K024120 — MODIFICATION TO TEMNO BIOPSY NEEDLES
- K023272 — DISPOSABLE ASPIRATION NEEDLE NA-200H
- K021847 — BIOPSY SCIENCES, LLC. MAXI-CELL BIOPSY NEEDLES
- K021525 — TOPCUT
- K013109 — SONOPSY
- K013069 — BIOSPEED
- K013070 — JAMSHIDI BIOPSY NEEDLE
- K013071 — SECURCUT ASPIRATION BIOPSY NEEDLE
- K012864 — INTERJECT INJECTION THERAPY NEEDLE, MODELS 1810, 1811, 1815, 1816, 1820, 1821, 1825, 1826, 1830, 1831, 1835, 1836
- K013356 — WILSON-COOK ULTRASOUND BIOPSY NEEDLE
- K012358 — CHIBA NEEDLE
- K011075 — EASYBELL
- K011270 — AUTOMATED CORE BIOPSY DEVICE
- K002944 — PRECISA BIOPSY NEEDLE
- K002946 — SILENT BIOPSY NEEDLE
- K002947 — BIOMOL ASPIRATION BIOPSY NEEDLE
- K991672 — OLYMPUS NA-10J-KB ASPIRATION NEEDLE
- K990220 — MODIFICATION OF GIP/MEDI-GLOBE ULTRASOUND NEEDLE SYSTEM
- K983218 — N,I.T., INC. AUTOMATIC CUTTING BIOPSY NEEDLE
- K981889 — WORLDWIDE MEDICAL TECHNOLOGIES INTRODUCER NEEDLE
- K963565 — MRI NEEDLES
- K971842 — COAXIAL NEEDLE
- K970563 — OLYMPUS NA-10J-1 ASPIRATION NEEDLE
- K963894 — SMARTGUIDE
- K961897 — WILSON-COOK BILIARY INTRODUCER WITH ASPIRATION BIOPSY NEEDLE
- K962569 — BIOMID BONE MARROW BIOPSY NEEDLE
- K962570 — ISAN STERNAL-ILIAC ASPIRATION BIOPSY NEEDLE
- K962568 — ACRI ILIAC CREST ASPIRATION BIOPSY NEEDLES
- K962905 — TX BIOPSY NEEDLE
- K961185 — DAUM BIOPSYNEEDLE
- K960317 — LAURUS NEEDLE CORE BIOPSY SYSTEM
- K943304 — 3D SURGICAL ENDOSCOPY SYSTEM FOR UROLOGY
- K951421 — GLOBAL MEDICAL PRODUCTS CHIBA, FRANSEEN, WESTCOTT STYLE, MENGHINI, TURNER, GREENE NEEDLES
- K954596 — PRO-B CORE-RECT COAXIAL BIOPSY SYSTEM
- K954231 — AUGASTROENTEROLOGY-UROLOGY BIOPSY INSTRUMENT
- K954155 — GREENE, TURNER, MENGHINI STYLE ASPIRATION BIOPSY NEEDLE
- K941722 — FNA BIOPSY NEEDLE
- K951598 — PRO-B BIOPSY NEEDLE
- K950982 — B. BRAUN SONOCAN BIOPSY NEEDLE AND ASPIRATION HANDLE
- K950810 — RUTNER BIOPSY DEVICE
- K935844 — GIP/MEDI-GLOBE NEEDLE SYSTEM FOR ULTRASONIC FNA
- K945813 — BECTON DICKINSON PRECISION CUT(TM) COAXIAL INTRODUCER NEEDLE WITH DEPTH STOP
- K945921 — ECHO STAR NEEDLE SET
- K944944 — CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE
- K945146 — CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE
- K945133 — MODIFIED BIOPSY NEEDLE
- K941563 — THE BIOPSY TOOL
- K934256 — GLOBAL MEDICAL CUTTING BIOPSY NEEDLE
Data sourced from openFDA. This site is unofficial and independent of the FDA.