Data / Medical devices / Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence
Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence (PWJ): 8 FDA-registered makers in 4 countries
8 establishments in 4 countries are registered with the FDA to make Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence (product code PWJ, Class 2, 21 CFR 884.4910). 5 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 5 510(k) clearances under this code, the latest on August 10, 2018, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PWJ
- Device class
- 2
- Regulation
- 884.4910
- Medical specialty
- Obstetrics/Gynecology
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| Switzerland | 2 |
| India | 1 |
| Malaysia | 1 |
Makers of Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Caldera Medical, Inc. | Westlake Village, CA, United States | Manufacturer, Repackager or relabeler, Specification developer | 4 | August 10, 2018 | 0 | 0 | 0 | api.fda.gov |
| Caldera Medical Sarl | Neuchatel, Switzerland | Specification developer | 3 | August 10, 2018 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Marlborough, MA, United States | Specification developer | 1 | December 20, 2017 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Spencer, IN, United States | Manufacturer | 1 | December 20, 2017 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer | 1 | December 20, 2017 | 0 | 0 | 0 | api.fda.gov |
| AUSA Medical Device Pvt Ltd | Bangalore Karnataka, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ethicon Sarl | Neuchatel, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sunningdale Tech Penang Sdn Bhd | Bandar Cassia Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 10, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.