| Device Type ID | 1748 |
| Device Name | Biopsy Needle |
| Regulation Description | Gastroenterology-urology Biopsy Instrument. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Urology And Lithotripsy Devices Branch (ULDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 876.1075 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FCG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 1748 |
| Device | Biopsy Needle |
| Product Code | FCG |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Gastroenterology-urology Biopsy Instrument. |
| CFR Regulation Number | 876.1075 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
APRIOMED AB | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BOSTON SCIENTIFIC CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BOSTON SCIENTIFIC CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COOK (CANADA), INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COOK ENDOSCOPY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COOK IRELAND LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COOK IRELAND LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CORBIN CLINICAL RESOURCES, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COVIDIEN LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COVIDIEN LLC (FORMERLY BEACON ENDOSCOPIC CORP) | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
H.S. HOSPITAL SERVICES S.P.A. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDI-GLOBE CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MERIT MEDICAL SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OLYMPUS MEDICAL SYSTEMS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
PFM MEDICAL, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WILSON COOK MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Break | 315 |
Needle | 251 |
Retraction Problem | 123 |
Bent | 112 |
Occlusion Within Device | 87 |
Kinked | 71 |
Adverse Event Without Identified Device Or Use Problem | 56 |
Material Deformation | 35 |
Tear, Rip Or Hole In Device Packaging | 18 |
Difficult To Remove | 16 |
Material Separation | 15 |
Material Perforation | 15 |
Detachment Of Device Or Device Component | 13 |
Fracture | 13 |
Tip | 12 |
Difficult To Advance | 12 |
Material Puncture / Hole | 11 |
Tip Breakage | 9 |
Device Markings / Labelling Problem | 8 |
Detachment Of Device Component | 8 |
Activation, Positioning Or Separation Problem | 7 |
Device Operational Issue | 6 |
Device Contamination With Chemical Or Other Material | 6 |
Material Fragmentation | 6 |
Needle, Separation | 5 |
Failure To Obtain Sample | 5 |
Material Twisted / Bent | 5 |
Failure To Fire | 4 |
No Apparent Adverse Event | 4 |
Appropriate Term/Code Not Available | 3 |
Improper Or Incorrect Procedure Or Method | 3 |
Lock | 3 |
Device Operates Differently Than Expected | 3 |
Coil | 3 |
Device-Device Incompatibility | 3 |
Mechanical Problem | 3 |
Insufficient Information | 2 |
Stylet | 2 |
Difficult To Insert | 2 |
Needle, Unsheathed | 2 |
Fitting Problem | 2 |
Device Issue | 2 |
Defective Component | 2 |
Failure To Advance | 2 |
Use Of Device Problem | 2 |
Endoscope | 1 |
Loss Of Or Failure To Bond | 1 |
Material Split, Cut Or Torn | 1 |
Device Dislodged Or Dislocated | 1 |
Failure To Transmit Record | 1 |
Wire | 1 |
Material Frayed | 1 |
Handpiece Break | 1 |
Product Quality Problem | 1 |
Expiration Date Error | 1 |
Wrinkled | 1 |
Migration Or Expulsion Of Device | 1 |
Device, Or Device Fragments Remain In Patient | 1 |
Material Protrusion / Extrusion | 1 |
Mechanical Jam | 1 |
Device Handling Problem | 1 |
Tube | 1 |
Device Misassembled During Manufacturing / Shipping | 1 |
Sticking | 1 |
Leak / Splash | 1 |
Unintended Movement | 1 |
Device Damaged Prior To Use | 1 |
Malfunction | 1 |
Hub | 1 |
Disconnection | 1 |
Flaked | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
Stretched | 1 |
Packaging Problem | 1 |
Defective Device | 1 |
Device Or Device Fragments Location Unknown | 1 |
Delivery System Failure | 1 |
| Total Device Problems | 1319 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Bard Peripheral Vascular Inc | II | Oct-02-2018 |
| 2 | Bard Peripheral Vascular Inc | II | Aug-16-2016 |
| 3 | Cook Inc. | II | Aug-22-2016 |
| 4 | Medtronic | II | Feb-28-2017 |