| Device Type ID | 3983 |
| Device Name | Insufflator, Laparoscopic |
| Regulation Description | Laparoscopic Insufflator. |
| 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 | 884.1730 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HIF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 3983 |
| Device | Insufflator, Laparoscopic |
| Product Code | HIF |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Laparoscopic Insufflator. |
| CFR Regulation Number | 884.1730 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BUFFALO FILTER, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CONMED | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
CONMED CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
FISHER & PAYKEL HEALTHCARE LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GYNETECH PTY. LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KARL STORZ GMBH & CO. KG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KARL STORZ SE & CO KG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LEXION MEDICAL, LLC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SOPRO - ACTEON GROUP | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SURGIQUEST, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 21 |
Device Operates Differently Than Expected | 8 |
Device Displays Incorrect Message | 5 |
Detachment Of Device Component | 5 |
Detachment Of Device Or Device Component | 5 |
Insufficient Information | 5 |
Break | 4 |
No Audible Alarm | 4 |
No Flow | 4 |
Infusion Or Flow Problem | 4 |
Fracture | 3 |
Inflation Problem | 3 |
Tear, Rip Or Hole In Device Packaging | 3 |
Thermal Decomposition Of Device | 3 |
Unexpected Shutdown | 3 |
Material Fragmentation | 2 |
Device Contamination With Chemical Or Other Material | 2 |
Alarm Not Visible | 2 |
Improper Flow Or Infusion | 2 |
Packaging Problem | 2 |
Device Inoperable | 2 |
Delivered As Unsterile Product | 2 |
Increase In Pressure | 1 |
Appropriate Term/Code Not Available | 1 |
Use Of Device Problem | 1 |
Failure To Deliver | 1 |
Device Dislodged Or Dislocated | 1 |
Power Problem | 1 |
Device Fell | 1 |
Inaccurate Flow Rate | 1 |
Misconnection | 1 |
Device Stops Intermittently | 1 |
Migration Or Expulsion Of Device | 1 |
Gas Leak | 1 |
Cap | 1 |
Mechanical Problem | 1 |
Overheating Of Device | 1 |
Noise, Audible | 1 |
Heat Exchanger | 1 |
Excessive Heating | 1 |
Patient Device Interaction Problem | 1 |
Valve, Relief | 1 |
Air Leak | 1 |
| Total Device Problems | 115 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | EXP Pharmaceutical Services Corp | II | Jul-24-2015 |
| 2 | Northgate Technologies, Inc. | II | Dec-21-2016 |
| 3 | Richard Wolf GmbH | II | May-14-2018 |
| 4 | Stryker Endoscopy | II | Apr-25-2016 |
| 5 | WOM World Of Medicine AG | II | Nov-27-2018 |