GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar— 510(k) K173019
Substantially EquivalentETHICON, Inc.
FDA 510(k) clearance K173019 for GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar, Substantially Equivalent on 2018-07-06. Applicant: ETHICON, Inc.. Device class: 2.
Clearance details
- Applicant
- ETHICON, Inc.
- Product code
- Code PWJ
- Device class
- Class 2
- Regulation
- 21 CFR 884.4910
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Somerville, NJ, US
Recent devices under product code PWJ
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- K172614 — Caldera Medical Transobturator Helical Introducer, Left +4 more
- K172565 — Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device
More clearances from ETHICON, Inc.
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- K253572 — STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX Spiral PRONOVA Bidirectional Knotless Tissue Control Device
- K253852 — MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture
- K252743 — STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device
Data sourced from openFDA. This site is unofficial and independent of the FDA.