510(k) K050355
K050355 is an FDA 510(k) premarket notification submitted by Tissue Science Laboratories, Plc for the device "PERMACOL SURGICAL IMPLANT T-PIECE, PERMACOL SURGICAL IMPLANT RECTOCELE-PIECE, MODELS 5928-150, 5645-150". The FDA issued a decision of Substantially Equivalent on March 9, 2005. The device falls under product code PAI (Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed), a Class III device regulated under 21 CFR 884.5980. Tissue Science Laboratories, Plc has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 9, 2005
- Date Received
- February 14, 2005
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical, Non-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 and uterine prolapse repair completed transvaginally.