| Device Type ID | 1960 |
| Device Name | Instrument, Biopsy |
| 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 | KNW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 1960 |
| Device | Instrument, Biopsy |
| Product Code | KNW |
| 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 | |
AVITUS ORTHOPAEDICS, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIOLOGIC THERAPIES INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIOPSYBELL S.R.L. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
C. R. BARD, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
C.R. BARD, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
CAREFUSION | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
COOK, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DEVICOR MEDICAL PRODUCTS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
HOLOGIC, INC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
HOLOGIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
INTACT MEDICAL CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
K2M | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
M.D.L. S.R.L. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDAX S.R.L. UNIPERSONALE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDAX SRL UNIPERSONALE | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MERIT MEDICAL SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MERMAID MEDICAL A/S | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MOLLER MEDICAL GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ORTHOVITA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RANFAC CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RANFAC, CORP | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SENORX, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SONTINA MEDICAL, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SPECTRA MEDICAL DEVICES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SPINESMITH HOLDINGS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STRYKER CORP. | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
STRYKER CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
VIDACARE LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Self-Activation Or Keying | 1321 |
Failure To Prime | 656 |
Failure To Obtain Sample | 273 |
Break | 271 |
Device Operates Differently Than Expected | 152 |
Failure To Fire | 138 |
Adverse Event Without Identified Device Or Use Problem | 97 |
Detachment Of Device Or Device Component | 81 |
Difficult To Remove | 69 |
Device Markings / Labelling Problem | 50 |
Device Contamination With Chemical Or Other Material | 40 |
Tear, Rip Or Hole In Device Packaging | 34 |
Bent | 29 |
Device Packaging Compromised | 26 |
Mechanical Problem | 23 |
Unsealed Device Packaging | 17 |
Failure To Cycle | 17 |
Material Twisted / Bent | 17 |
Crack | 15 |
Packaging Problem | 15 |
Probe | 14 |
Noise, Audible | 13 |
Needle | 11 |
Sticking | 10 |
Detachment Of Device Component | 9 |
Device Inoperable | 8 |
Misfire | 8 |
Device Difficult To Setup Or Prepare | 8 |
Suction Problem | 7 |
Insufficient Information | 7 |
Filling Problem | 6 |
Material Separation | 6 |
Separation Failure | 6 |
Melted | 6 |
Use Of Device Problem | 5 |
Device Displays Incorrect Message | 5 |
Failure To Reset | 5 |
Material Integrity Problem | 5 |
Electronic Property Issue | 5 |
Device-Device Incompatibility | 5 |
Fluid Leak | 5 |
Decrease In Suction | 5 |
Dull, Blunt | 5 |
Failure To Disconnect | 4 |
Difficult To Position | 4 |
Device Misassembled During Manufacturing / Shipping | 4 |
Material Fragmentation | 4 |
Fracture | 4 |
Difficult To Open Or Close | 4 |
Failure To Cut | 4 |
Unintended Ejection | 3 |
Shipping Damage Or Problem | 3 |
Connection Problem | 3 |
Device Operational Issue | 3 |
Improper Or Incorrect Procedure Or Method | 3 |
Expulsion | 3 |
Mechanical Jam | 3 |
Leak / Splash | 3 |
Fitting Problem | 3 |
Premature Activation | 3 |
Device Slipped | 3 |
Overheating Of Device | 3 |
Difficult To Insert | 3 |
Mechanics Altered | 3 |
Nonstandard Device | 2 |
Physical Resistance / Sticking | 2 |
Device Handling Problem | 2 |
Defective Component | 2 |
Suction Failure | 2 |
Contamination During Use | 2 |
Valve | 2 |
Label | 2 |
Smoking | 2 |
No Display / Image | 2 |
Material Invagination | 1 |
Retraction Problem | 1 |
Device Dislodged Or Dislocated | 1 |
Tip | 1 |
No Apparent Adverse Event | 1 |
Appropriate Term/Code Not Available | 1 |
Material Split, Cut Or Torn | 1 |
Metal Shedding Debris | 1 |
Failure To Calibrate | 1 |
Deformation Due To Compressive Stress | 1 |
Activation, Positioning Or Separation Problem | 1 |
Circuit Failure | 1 |
Misassembled | 1 |
Wire | 1 |
Inappropriate Or Unexpected Reset | 1 |
Cannula | 1 |
Application Program Freezes, Becomes Nonfunctional | 1 |
Unraveled Material | 1 |
Driver | 1 |
Pin | 1 |
Failure To Adhere Or Bond | 1 |
Material Discolored | 1 |
Unstable | 1 |
Vibration | 1 |
Power Problem | 1 |
Device Contamination With Body Fluid | 1 |
| Total Device Problems | 3621 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Argon Medical Devices, Inc | II | Feb-13-2017 |
| 2 | Argon Medical Devices, Inc | II | Jul-21-2015 |
| 3 | Avitus Orthopaedics, Inc. | II | Mar-23-2019 |
| 4 | Bard Peripheral Vascular Inc | II | Oct-20-2017 |
| 5 | Bard Peripheral Vascular Inc | II | May-06-2015 |
| 6 | Bard Peripheral Vascular Inc | II | Apr-14-2015 |
| 7 | Cook Medical Incorporated | II | Oct-24-2014 |
| 8 | Devicor Medical Products Inc | II | Mar-08-2017 |
| 9 | Hologic, Inc | II | Sep-21-2016 |
| 10 | Medtronic Advanced Energy, LLC | II | Feb-02-2017 |
| 11 | Orthovita, Inc., DBA Stryker Orthobiologics. | II | Jan-07-2015 |
| 12 | Stryker Instruments Div. Of Stryker Corporation | II | Jul-18-2015 |
| 13 | Stryker Instruments Div. Of Stryker Corporation | II | May-26-2015 |
| 14 | Teleflex Medical | II | Nov-30-2016 |