Definition: Used To Aid In Insertion, Placement, Fixation, Or Anchoring Of Surgical Mesh For Transvaginal Pelvic Organ Prolapse Repair
| Device Type ID | 4101 |
| Device Name | Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse |
| Physical State | Needle Passers And Trocars, Needle Guides, Fixation Tools, And Tissue Anchors Used With Urogynecologic Surgical Mesh |
| Technical Method | Used With Urogynecologic Surgical Mesh Instrumentation To Facilitate Transvaginal Pelvic Organ Prolapse Repair Procedures |
| Target Area | Vagina, Pelvic Floor, Uterus |
| Regulation Description | Specialized Surgical Instrumentation For Use With Urogynecologic Surgical Mesh. |
| 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 | 884.4910 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PWI |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4101 |
| Device | Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse |
| Product Code | PWI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Specialized Surgical Instrumentation For Use With Urogynecologic Surgical Mesh. |
| CFR Regulation Number | 884.4910 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BOSTON SCIENTIFIC CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BOSTON SCIENTIFIC CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COLOPLAST MANUFACTURING US LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Break | 1 |
Insufficient Information | 1 |
| Total Device Problems | 2 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Boston Scientific Corporation | II | May-04-2018 |