Definition: Attaching Suture Or Stapling Ligaments Of The Pelvic Floor.
| Device Type ID | 4077 |
| Device Name | Fixation, Non-absorbable Or Absorbable, For Pelvic Use |
| Physical State | Non-absorbable Or Absorbable Suture Or Staple; May Include Instruments And/or Tissue Anchoring Components As Part Of A Kit |
| Technical Method | Provides Mechanism For Attachment To And/or From Ligaments Of The Pelvic Floor |
| Target Area | Uterus, Vagina, Pelvic Floor |
| 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 | PBQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4077 |
| Device | Fixation, Non-absorbable Or Absorbable, For Pelvic Use |
| Product Code | PBQ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Obstetric-gynecologic Specialized Manual Instrument. |
| CFR Regulation Number | 884.4530 [🔎] |
| Device Problems | |
|---|---|
Material Erosion | 1 |
| Total Device Problems | 1 |