Definition: Call For PMAs To Be Filed By 12/30/87 (52 FR 36883 (10/1/87))
| Device Type ID | 4000 |
| Device Name | Laparoscopic Contraceptive Tubal Occlusion Device |
| Regulation Description | Contraceptive Tubal Occlusion Device (TOD) And Introducer. |
| 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 | PMA |
| CFR Regulation Number | 884.5380 [🔎] |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | KNH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4000 |
| Device | Laparoscopic Contraceptive Tubal Occlusion Device |
| Product Code | KNH |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Contraceptive Tubal Occlusion Device (TOD) And Introducer. |
| CFR Regulation Number | 884.5380 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 22 |
Unsealed Device Packaging | 20 |
Break | 11 |
Appropriate Term/Code Not Available | 8 |
Patient-Device Incompatibility | 7 |
Device Operates Differently Than Expected | 6 |
Insufficient Information | 6 |
Applicator | 5 |
Difficult To Remove | 4 |
Migration | 3 |
Activation, Positioning Or Separation Problem | 3 |
Positioning Failure | 3 |
Expulsion | 3 |
Premature Activation | 3 |
Entrapment Of Device | 3 |
Difficult To Insert | 2 |
Device Or Device Fragments Location Unknown | 2 |
Separation Failure | 2 |
Device Dislodged Or Dislocated | 2 |
No Apparent Adverse Event | 2 |
Extrusion | 2 |
Migration Or Expulsion Of Device | 2 |
Human-Device Interface Problem | 1 |
Device Fell | 1 |
Product Quality Problem | 1 |
Device Appears To Trigger Rejection | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
Delivered As Unsterile Product | 1 |
Misfire | 1 |
Unintended Ejection | 1 |
Use Of Device Problem | 1 |
Device Packaging Compromised | 1 |
Coil | 1 |
Detachment Of Device Component | 1 |
Detachment Of Device Or Device Component | 1 |
Mechanical Problem | 1 |
Malposition Of Device | 1 |
Biocompatibility | 1 |
Positioning Problem | 1 |
| Total Device Problems | 138 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Gyrus Acmi, Incorporated | II | Jun-26-2015 |
| 2 | Gyrus Medical, Inc | II | Aug-19-2014 |
| 3 | Gyrus Medical, Inc | II | Mar-13-2014 |
| 4 | Richard Wolf Medical Instruments Corp. | II | Nov-06-2014 |