Permacol Surgical Implant T-Piece, Permacol Surgical Implant Rectocele-Piece, Models 5928-150, 5645-150

FDA 510(k) K050355 · Tissue Science Laboratories, Plc

Substantially Equivalent

510(k) numberK050355

Submission

Device name
Permacol Surgical Implant T-Piece, Permacol Surgical Implant Rectocele-Piece, Models 5928-150, 5645-150
Applicant
Tissue Science Laboratories, Plc
Covington, GA, US
Received
February 14, 2005
Decision date
March 9, 2005
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
PAI – Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
Device class
Class III (high risk)
Regulation
21 CFR 884.5980
Specialty
Obstetrics/Gynecology
Implant
Yes

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.

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Questions and answers

When was Permacol Surgical Implant T-Piece, Permacol Surgical Implant Rectocele-Piece, Models 5928-150, 5645-150 cleared by the FDA?

Permacol Surgical Implant T-Piece, Permacol Surgical Implant Rectocele-Piece, Models 5928-150, 5645-150 (K050355) received a 510(k) decision of Substantially Equivalent on March 9, 2005, 23 days after the submission was received.

What is the product code of K050355?

The FDA product code is PAI – Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed, a Class III (high risk) device regulated under 21 CFR 884.5980.