510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K083839Substantially Equivalent

Avaulta Solo Synthetic Support System, Avaulta Plus Biosynthetic Support System

C.R. Bard Inc, Covington GA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K083839 is the FDA 510(k) clearance record for AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM, a class III device, cleared for C.R. Bard, Inc. on under FDA product code OTP (Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed). FDA's definition for product code OTP 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 or uterine prolapse repair performed...". FDA records list 646 510(k) clearances for C.R. Bard, Inc., from to . As of , FDA records show no recalls naming K083839.

Clearance record

Decision date
Received
(23 days to decision)
Product code
OTP Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
Regulation
21 CFR 884.5980
Device class
Class III
Review panel
Obstetrics/Gynecology
Applicant
C.R. Bard, Inc. 13183 Harland Dr., Covington GA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OTP

Trailing 12 months

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

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