| Device Type ID | 3993 |
| Device Name | Instrument, Manual, Specialized Obstetric-gynecologic |
| 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 | KNA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3993 |
| Device | Instrument, Manual, Specialized Obstetric-gynecologic |
| Product Code | KNA |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Obstetric-gynecologic Specialized Manual Instrument. |
| CFR Regulation Number | 884.4530 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
PANPAC MEDICAL CORPO | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PANPAC MEDICAL CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Leak / Splash | 14 |
Material Rupture | 12 |
Adverse Event Without Identified Device Or Use Problem | 8 |
Inflation Problem | 7 |
Deflation Problem | 6 |
Break | 5 |
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 4 |
Appropriate Term/Code Not Available | 4 |
Burst Container Or Vessel | 4 |
Device Operates Differently Than Expected | 4 |
Balloon | 3 |
Partial Blockage | 3 |
Detachment Of Device Component | 3 |
Hole In Material | 2 |
Fluid Leak | 2 |
Balloon Rupture | 2 |
Component Missing | 2 |
Device Dislodged Or Dislocated | 1 |
Unintended Ejection | 1 |
Contamination / Decontamination Problem | 1 |
Connection Problem | 1 |
Device Operational Issue | 1 |
Fracture | 1 |
Migration Or Expulsion Of Device | 1 |
Defective Component | 1 |
Material Integrity Problem | 1 |
Migration | 1 |
Blocked Connection | 1 |
Insufficient Information | 1 |
Component(s), Broken | 1 |
Kinked | 1 |
Material Separation | 1 |
| Total Device Problems | 100 |