| Device Type ID | 3985 |
| Device Name | Hysteroscope (and Accessories) |
| Regulation Description | Hysteroscope And Accessories. |
| Regulation Medical Specialty | Obstetrics/Gynecology |
| Review Panel | Obstetrics/Gynecology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Obstetrics And Gynecology Devices Branch (OGDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 884.1690 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HIH |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 3985 |
| Device | Hysteroscope (and Accessories) |
| Product Code | HIH |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Hysteroscope And Accessories. |
| CFR Regulation Number | 884.1690 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BOSTON SCIENTIFIC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BOSTON SCIENTIFIC CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COOPERSURGICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
COVIDIEN | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ENDOSEC CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HOLOGIC, INC | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
HOLOGIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
LINA MEDICAL APS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NVISION MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
POLYGON MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SMITH & NEPHEW, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Break | 302 |
Adverse Event Without Identified Device Or Use Problem | 83 |
Material Separation | 42 |
Tip | 33 |
Material Opacification | 27 |
Detachment Of Device Component | 24 |
Mechanics Altered | 11 |
Mechanical Jam | 10 |
Material Fragmentation | 10 |
Appropriate Term/Code Not Available | 10 |
Device Handling Problem | 8 |
Bent | 7 |
Overheating Of Device | 6 |
Fracture | 5 |
Product Quality Problem | 4 |
Suction Problem | 4 |
Jaw | 4 |
Detachment Of Device Or Device Component | 4 |
Mechanical Problem | 4 |
Component Falling | 4 |
Difficult To Insert | 3 |
Device Damaged Prior To Use | 3 |
Material Perforation | 3 |
Leak / Splash | 3 |
Component Missing | 3 |
Failure To Cut | 3 |
Device Difficult To Setup Or Prepare | 3 |
Fire | 3 |
Device Operates Differently Than Expected | 2 |
Defective Component | 2 |
Cord | 2 |
Material Deformation | 2 |
Dent In Material | 2 |
Device Packaging Compromised | 2 |
Microbial Contamination Of Device | 2 |
Failure To Align | 1 |
Defective Device | 1 |
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 1 |
Display Or Visual Feedback Problem | 1 |
Fluid Leak | 1 |
Temperature Problem | 1 |
Insufficient Information | 1 |
Dull, Blunt | 1 |
Positioning Problem | 1 |
Scratched Material | 1 |
Material Protrusion / Extrusion | 1 |
Device Emits Odor | 1 |
Arcing | 1 |
Device, Removal Of (non-implant) | 1 |
Electrical Shorting | 1 |
Fitting Problem | 1 |
Endoscope | 1 |
Disassembly | 1 |
No Display / Image | 1 |
Melted | 1 |
Material Puncture / Hole | 1 |
Smoking | 1 |
Metal Shedding Debris | 1 |
Electrode | 1 |
Failure To Calibrate | 1 |
Difficult Or Delayed Positioning | 1 |
Misfire | 1 |
Connection Problem | 1 |
Flare Or Flash | 1 |
Material Integrity Problem | 1 |
Difficult To Remove | 1 |
Communication Or Transmission Problem | 1 |
| Total Device Problems | 672 |