| Device Type ID | 5505 |
| Device Name | Lancet, Blood |
| Regulation Description | Manual Surgical Instrument For General Use. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Center For Biologics Evaluation & Research (CBER) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.4800 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | FMK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5505 |
| Device | Lancet, Blood |
| Product Code | FMK |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Manual Surgical Instrument For General Use. |
| CFR Regulation Number | 878.4800 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
GENTEEL, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Retraction Problem | 1697 |
Mechanism | 336 |
Physical Property Issue | 44 |
Mechanical Problem | 29 |
Break | 23 |
Needle | 23 |
Material Fragmentation | 23 |
Material Integrity Problem | 23 |
Failure To Align | 21 |
Mechanics Altered | 21 |
Delivered As Unsterile Product | 19 |
Difficult Or Delayed Activation | 18 |
Product Quality Problem | 16 |
Spring | 13 |
Material Protrusion / Extrusion | 9 |
Packaging Problem | 9 |
Misfire | 9 |
Adverse Event Without Identified Device Or Use Problem | 8 |
Device Operational Issue | 8 |
Incorrect Or Inadequate Test Results | 8 |
Device Damaged Prior To Use | 8 |
Spring Loading Mechanism | 7 |
Detachment Of Device Or Device Component | 7 |
Device Operates Differently Than Expected | 7 |
Failure To Fire | 7 |
Defective Component | 6 |
Component Missing | 6 |
Device Markings / Labelling Problem | 6 |
Fail-Safe Problem | 5 |
Appropriate Term/Code Not Available | 4 |
Fail-Safe Did Not Operate | 4 |
Protective Measures Problem | 4 |
Complete Blockage | 4 |
Material Separation | 4 |
Leak / Splash | 4 |
Device Contamination With Chemical Or Other Material | 4 |
Delivery System Failure | 3 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 3 |
Infusion Or Flow Problem | 3 |
Material Twisted / Bent | 3 |
Cap | 3 |
Obstruction Of Flow | 3 |
Occlusion Within Device | 3 |
Melted | 2 |
Bent | 2 |
Insufficient Information | 2 |
Manufacturing, Packaging Or Shipping Problem | 2 |
Material Deformation | 2 |
Out-Of-Box Failure | 2 |
Device Handling Problem | 2 |
Pump | 1 |
Inadequate Or Insufficient Training | 1 |
Component Incompatible | 1 |
Unsealed Device Packaging | 1 |
Unintended Movement | 1 |
Failure To Obtain Sample | 1 |
Device Misassembled During Manufacturing / Shipping | 1 |
Detachment Of Device Component | 1 |
Loose Or Intermittent Connection | 1 |
Volume Accuracy Problem | 1 |
Device Slipped | 1 |
Crack | 1 |
No Device Output | 1 |
Premature Activation | 1 |
Fracture | 1 |
Expiration Date Error | 1 |
Patient-Device Incompatibility | 1 |
Device Contamination With Body Fluid | 1 |
Failure To Advance | 1 |
Device Inoperable | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Holder | 1 |
Test Strip | 1 |
Disassembly | 1 |
Use Of Device Problem | 1 |
Failure To Cut | 1 |
Device Dislodged Or Dislocated | 1 |
Failure To Eject | 1 |
| Total Device Problems | 2507 |