PWJ

5 FDA 510(k) clearances · Product code

246 daysmedian time to decision

281 days90th percentile

5clearances measured

FDA profile

Official device name: Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence
Device class: Class II (moderate risk)
Regulation: 21 CFR 884.4910
Medical specialty: Obstetrics/Gynecology
FDA definition: Used to aid in insertion, placement, fixation, or anchoring of surgical mesh for stress urinary incontinence

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Record	Firm	Date
GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System (K181151)	ETHICON, Inc.	2018-08-10
GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar (K173019)	ETHICON, Inc.	2018-07-06
GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide (K173162)	ETHICON, Inc.	2018-06-28
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 (K172614)	Caldera Medical, Inc.	2018-05-04
Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device (K172565)	Boston Scientific Corporation	2017-12-20

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Every clearance here is in the API, with alerts when new ones post.