510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K173019Substantially Equivalent

GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar

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

K173019 is the FDA 510(k) clearance record for GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar, a class II device, cleared for ETHICON, Inc. on under FDA product code PWJ (Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence). FDA's definition for product code PWJ reads: "Used to aid in insertion, placement, fixation, or anchoring of surgical mesh for stress urinary incontinence". FDA records list 208 510(k) clearances for ETHICON, Inc., from to . As of , FDA records show no recalls naming K173019.

Clearance record

Decision date
Received
(281 days to decision)
Product code
PWJ Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence
Regulation
21 CFR 884.4910
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
ETHICON, Inc. Rte. 22 W., Somerville NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PWJ

Trailing 12 months

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

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