510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K130006Substantially Equivalent

Biodesign Surgisis Anterior Posterior Pelvic Floor Grafts

Cook Biotech Incorporated, West Lafayette IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K130006 is the FDA 510(k) clearance record for BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS, a class III device, cleared for Cook Biotech Incorporated on under FDA product code PAI (Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed). FDA's definition for product code PAI reads: "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...". FDA records list 16 510(k) clearances for Cook Biotech Incorporated, from to . As of , FDA records show no recalls naming K130006.

Clearance record

Decision date
Received
(93 days to decision)
Product code
PAI Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
Regulation
21 CFR 884.5980
Device class
Class III
Review panel
Obstetrics/Gynecology
Applicant
Cook Biotech Incorporated 1425 Innovation Pl., West Lafayette IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PAI

Trailing 12 months

FDA records hold no clearances under product code PAI in the trailing twelve months.

FDA records show no clearances under product code PAI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PAI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260