510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K982403Substantially Equivalent

Brennen Biosynthetic Surgical Mesh Matrix

Brennen Medical, Inc., St. Paul MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K982403 is the FDA 510(k) clearance record for BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX, a class II device, cleared for Brennen Medical, Inc. on under FDA product code PAG (Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator). FDA's definition for product code PAG reads: "Transvaginal surgical repair of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) and/or urethral hypermobility". FDA records list 20 510(k) clearances for Brennen Medical, Inc., from to . As of , FDA records show no recalls naming K982403.

Clearance record

Decision date
Received
(74 days to decision)
Product code
PAG Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Brennen Medical, Inc. 1290 Hammond Rd., St. Paul MN
510(k) summary
Statement
Third party review
No

Clearances, product code PAG

Trailing 12 months

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

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