510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K052401Substantially Equivalent

Gynecare Tvt Secur System

Ethicon, Inc, Somerville NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K052401 is the FDA 510(k) clearance record for GYNECARE TVT SECUR SYSTEM, a class II device, cleared for ETHICON, Inc. on under FDA product code PAH (Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling). FDA's definition for product code PAH reads: "Transvaginal surgical repair of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) and/or urethral hypermobility". FDA records list 208 510(k) clearances for ETHICON, Inc., from to . As of , FDA records show no recalls naming K052401.

Clearance record

Decision date
Received
(88 days to decision)
Product code
PAH Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
ETHICON, Inc. P.O Box 151, Rte. 22 W., Somerville NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PAH

Trailing 12 months

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

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