Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse
The Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse is an obstetrics/gynecology device consisting of instruments used to aid in the insertion, placement, fixation, or anchoring of surgical mesh during transvaginal repair of pelvic organ prolapse, a condition in which pelvic organs descend into or outside of the vagina. It is classified as FDA Class II under regulation 21 CFR 884.4910, requiring 510(k) premarket notification clearance and compliance with general and special controls. The product code is PWI and it falls under the Obstetrics/Gynecology medical specialty. It is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- PWI
- Device Class
- FDA class 2
- Regulation Number
- 884.4910
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 1
Device Characteristics
Definition
Used to aid in insertion, placement, fixation, or anchoring of surgical mesh for transvaginal pelvic organ prolapse repair
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.