PWJ is the FDA product code for Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence, a class II device type, regulated under 21 CFR 884.4910. FDA's definition for this code reads: "Used to aid in insertion, placement, fixation, or anchoring of surgical mesh for stress urinary incontinence". As of 2026-09-10 , FDA records hold 5 510(k) clearances under this code, the most recent dated 2018-08-10 , and no recalls.
Classification record Product code PWJ Device name Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence FDA definition Used to aid in insertion, placement, fixation, or anchoring of surgical mesh for stress urinary incontinence Regulation 21 CFR 884.4910 Device class Class II Review panel Obstetrics/Gynecology Submission type 510(k) Implant No Life sustaining or supporting No GMP exempt No Third party review eligible No Ingested clearances 5 Ingested recalls 0
Clearances, product code PWJ By decision year 5 clearances under product code PWJ with a decision year between 2017 and 2018, 2018 the highest year at 4. Show the numbers
Applicants with the most clearances Product code PWJ
Companies listing this code with FDA Companies whose registered establishments list this code FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
Recent clearances Product code PWJ K181151 Class II GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System ETHICON, Inc. / cleared 2018-08-10 K173019 Class II GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar ETHICON, Inc. / cleared 2018-07-06 K173162 Class II GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide ETHICON, Inc. / cleared 2018-06-28 K172614 Class II Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transobturator Helical Introducer, Right; Caldera Medical Transobturator Large Helical Introducer, Left; Caldera Medical Transobturator Large Helical Introducer, Right; Caldera Medical Transobturator Inside-Out Introducer, Left Caldera Medical, Inc. / cleared 2018-05-04 K172565 Class II Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device Boston Scientific Corporation / cleared 2017-12-20
Recent recalls Product code PWJ FDA records show no recalls under product code PWJ.
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About this record Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.
MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.
Data as of 2026-10-05 , the FDA export date for this dataset. Page last changed 2026-09-05 . View this product code on fda.gov ↗ (opens on fda.gov)
