| Device Type ID | 3918 |
| Device Name | Laparoscope, Gynecologic (and Accessories) |
| Regulation Description | Gynecologic Laparoscope 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 | 884.1720 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HET |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 3918 |
| Device | Laparoscope, Gynecologic (and Accessories) |
| Product Code | HET |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Gynecologic Laparoscope And Accessories. |
| CFR Regulation Number | 884.1720 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
KARL STORZ GMBH & CO. KG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KARL STORZ SE & CO KG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDROBOTICS CORP | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OLYMPUS MEDICAL SYSTEMS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
W.O.M. WORLD OF MEDICINE AG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Appropriate Term/Code Not Available | 182 |
Break | 39 |
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 23 |
Physical Resistance | 20 |
Adverse Event Without Identified Device Or Use Problem | 19 |
Failure To Cut | 15 |
Device Operates Differently Than Expected | 10 |
Torn Material | 10 |
Detachment Of Device Component | 8 |
Leak / Splash | 5 |
Detachment Of Device Or Device Component | 5 |
Material Integrity Problem | 5 |
No Display / Image | 5 |
Material Separation | 4 |
Material Fragmentation | 3 |
Output Problem | 3 |
Fluid Leak | 3 |
Dull, Blunt | 3 |
Use Of Device Problem | 3 |
Fracture | 3 |
Migration Or Expulsion Of Device | 2 |
Improper Device Output | 2 |
Tip | 2 |
Electrical /Electronic Property Problem | 2 |
Mechanical Problem | 2 |
No Device Output | 2 |
Insufficient Information | 2 |
False Device Output | 2 |
Out-Of-Box Failure | 2 |
Device Contaminated During Manufacture Or Shipping | 2 |
Material Deformation | 2 |
Arcing | 1 |
Mechanical Jam | 1 |
Protective Measures Problem | 1 |
Misassembly By Users | 1 |
Hole In Material | 1 |
Unsealed Device Packaging | 1 |
Improper Flow Or Infusion | 1 |
Overheating Of Device | 1 |
Failure To Align | 1 |
Defective Device | 1 |
Labelling, Instructions For Use Or Training Problem | 1 |
Display Or Visual Feedback Problem | 1 |
Thermal Decomposition Of Device | 1 |
Component Falling | 1 |
Failure To Conduct | 1 |
Decrease In Suction | 1 |
Misassembled | 1 |
Jaw | 1 |
Material Split, Cut Or Torn | 1 |
Suction Problem | 1 |
Component Missing | 1 |
Melted | 1 |
Smoking | 1 |
Difficult To Open Or Close | 1 |
Sediment, Precipitate Or Deposit In Device Or Device Ingredient | 1 |
Hose | 1 |
Corroded | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
Electronic Property Issue | 1 |
Bent | 1 |
Material Disintegration | 1 |
Sparking | 1 |
| Total Device Problems | 422 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Market-Tiers Inc | II | Aug-02-2014 |
| 2 | Olympus Corporation Of The Americas | II | Feb-21-2017 |
| 3 | Olympus Corporation Of The Americas | II | Dec-10-2015 |