| Device Type ID | 4008 |
| Device Name | Cannula, Manipulator/injector, Uterine |
| Regulation Description | Obstetric-gynecologic Specialized Manual Instrument. |
| 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 | 884.4530 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LKF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4008 |
| Device | Cannula, Manipulator/injector, Uterine |
| Product Code | LKF |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Obstetric-gynecologic Specialized Manual Instrument. |
| CFR Regulation Number | 884.4530 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ARGON MEDICAL DEVICES, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BEIJING HANGTIAN KADI TECHNOLOGY R&D INSTITUTE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CLEARPATH SURGICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CLINICAL INNOVATIONS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CONMED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CONMED CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COOK, INC. | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
COOPER SURGICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COOPERSURGICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
CROSSBAY MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GYNETECH PTY. LTD. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Detachment Of Device Component | 12 |
Material Fragmentation | 10 |
Break | 9 |
Detachment Of Device Or Device Component | 8 |
Catheter | 6 |
Material Separation | 3 |
Human Factors Issue | 2 |
Appropriate Term/Code Not Available | 2 |
Improper Or Incorrect Procedure Or Method | 2 |
Human-Device Interface Problem | 2 |
Fracture | 1 |
Inflation Problem | 1 |
Misconnection | 1 |
Disassembly | 1 |
Melted | 1 |
Unknown (for Use When The Device Problem Is Not Known) | 1 |
Overfill | 1 |
Maintenance Does Not Comply To Manufacturers Recommendations | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Device, Removal Of (non-implant) | 1 |
Packaging Problem | 1 |
Insufficient Information | 1 |
Device Or Device Fragments Location Unknown | 1 |
Malposition Of Device | 1 |
| Total Device Problems | 70 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | CooperSurgical, Inc. | II | Jun-08-2015 |
| 2 | CooperSurgical, Inc. | II | Sep-05-2014 |
| 3 | CooperSurgical, Inc. | II | Jun-11-2014 |