Device Type ID | 3904 |
Device Name | Set, Anesthesia, Paracervical |
Regulation Description | Obstetric Anesthesia Set. |
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 | 884.5100 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | HEE |
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 | 3904 |
Device | Set, Anesthesia, Paracervical |
Product Code | HEE |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Obstetric Anesthesia Set. |
CFR Regulation Number | 884.5100 [🔎] |
Recalls | |||
---|---|---|---|
Manufacturer | Recall Class | Date Posted | |
1 | CooperSurgical, Inc. | III | Oct-06-2015 |