Definition: Exempt Laparoscope Accessories Are Non-powered, Non-inflatable, Simple Manual Mechanical Devices, E.g., Cannula, Graspers, Forceps, Dissectors, Scissors, Etc. A Gynecologic Laparoscope Is A Device Used To Permit Direct Viewing Of The Organs Within Th
| Device Type ID | 4050 |
| Device Name | Laparoscopic Accessories, Gynecologic |
| Physical State | Metal Instruments |
| Technical Method | Part Of A System Where The Accessories Advance The Working Channel Of The Laparoscope To Perform It's Function. |
| Target Area | Abdominal Cavity. |
| 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) Exempt |
| CFR Regulation Number | 884.1720 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | NWV |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4050 |
| Device | Laparoscopic Accessories, Gynecologic |
| Product Code | NWV |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Gynecologic Laparoscope And Accessories. |
| CFR Regulation Number | 884.1720 [🔎] |
| Device Problems | |
|---|---|
Detachment Of Device Component | 17 |
Break | 16 |
Material Fragmentation | 13 |
Device Operates Differently Than Expected | 7 |
Adverse Event Without Identified Device Or Use Problem | 6 |
Mechanical Problem | 6 |
Detachment Of Device Or Device Component | 6 |
Defective Device | 4 |
Material Separation | 4 |
Mechanical Jam | 3 |
Device Contamination With Biological Material | 1 |
Physical Resistance / Sticking | 1 |
Entrapment Of Device | 1 |
Difficult To Advance | 1 |
Disassembly | 1 |
Use Of Device Problem | 1 |
Difficult To Open Or Close | 1 |
Fracture | 1 |
Product Quality Problem | 1 |
Material Integrity Problem | 1 |
| Total Device Problems | 92 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Cook Inc. | II | Jun-14-2017 |
| 2 | JosNoe Medical, Inc. | II | Jan-30-2016 |