Device Type ID | 3994 |
Device Name | Instrument, Destructive, Fetal, Obstetric |
Regulation Description | Obstetric Fetal Destructive 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 | 884.4500 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | KNB |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
Device Type ID | 3994 |
Device | Instrument, Destructive, Fetal, Obstetric |
Product Code | KNB |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Obstetric Fetal Destructive Instrument. |
CFR Regulation Number | 884.4500 [🔎] |