Pubouurethral Sling
by Ethicon Inc.
510(k) K974098
Pubouurethral Sling is a Class II device made by Ethicon Inc., cleared under FDA 510(k) K974098 on 28 Jan 1998, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK974098 | Date28 Jan 1998 | StatusActive |
Official records
- FDA 510(k) database K974098
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OTN
- FDA applicant
- ETHICON, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 878.3300
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code OTN (Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator).
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- RETROARC RETROPUBIC SLING SYSTEM by AMERICAN MEDICAL SYSTEMS, INC.
- DESARA MESH by CALDERA MEDICAL, INC.
- Remeex System -Readjustment kit AR-01 by DESARROLLO E INVESTIGACION MEDICA ARAGONESA SL
- TRIANGLE SLING by Influence, Inc.
- ArcTO Transobturator Sling System by Urocure, LLC
- URETEX TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM by SOFRADIM PRODUCTION
- MENTOR ARIS TRANS-OBTURATOR TAPE AND SURGICAL KIT by Mentor Corp.
- OMNISURE URETHRAL SLING, MODEL OTK52 by Mpathy Medical Devices, Ltd.
- KIM (Knotless Incontinence Mesh) KIM-01 by DESARROLLO E INVESTIGACION MEDICA ARAGONESA SL