Device |
fixation, non-absorbable or absorbable, for pelvic use |
Regulation Description |
Obstetric-gynecologic specialized manual instrument. |
Definition |
Attaching suture or stapling ligaments of the pelvic floor. |
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 Medical Specialty |
Obstetrics/Gynecology |
Review Panel |
Obstetrics/Gynecology |
Product Code | PBQ |
Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Reproductive, Gynecology and Urology Devices
(DHT3B)
|
Submission Type |
510(k)
|
Regulation Number |
884.4530
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
Yes
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |