510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K002233Substantially Equivalent

Bvi Sling

Bio-Vascular, Inc., St. Paul MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K002233 is the FDA 510(k) clearance record for BVI SLING, a class II device, cleared for Bio-Vascular, Inc. on under FDA product code PAJ (Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed). FDA's definition for product code PAJ reads: "Bridging material to attach the vaginal apex or uterus to the sacral promontory; procedures include abdominal sacrocolpopexy, laparoscopic sacrocolpopexy and robot-assisted sacrocolpopexy". FDA records list 26 510(k) clearances for Bio-Vascular, Inc., from to . As of , FDA records show one recall naming K002233.

Clearance record

Decision date
Received
(81 days to decision)
Product code
PAJ Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Bio-Vascular, Inc. 2575 University Ave., St. Paul MN
510(k) summary
Summary
Third party review
No

Clearances, product code PAJ

Trailing 12 months

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

FDA records show no clearances under product code PAJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PAJ, 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