510(k) K112386
K112386 is an FDA 510(k) premarket notification submitted by Coloplast Corp. for the device "EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM". The FDA issued a decision of Substantially Equivalent on September 8, 2011. The device falls under product code OTP (Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed), a Class III device regulated under 21 CFR 884.5980. Coloplast Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 8, 2011
- Date Received
- August 18, 2011
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
- Device Class
- Class III
- Regulation Number
- 884.5980
- Review Panel
- OB
- Submission Type
Tissue reinforcement of the fibromuscular layer of the pelvic floor when surgical treatment is indicated; Procedures include anterior and posterior vaginal wall prolapse repair and vaginal apical or uterine prolapse repair performed transvaginally