Data / Medical devices / Switzerland / Caldera Medical Sarl
Caldera Medical Sarl: FDA-registered device maker in Neuchatel, Switzerland, 9 510(k) clearances
Caldera Medical Sarl is registered with the FDA (registration 3039118206) in Neuchatel, Switzerland. It lists 2 device types. The FDA files 9 510(k) clearances under its listings, the newest dated September 17, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3039118206
- Address
- Rue du Puits-Godet 20, Neuchatel, Switzerland, 2000
- Owner or operator
- Caldera Medical Sarl (10096192)
- Roles
- Specification developer
- First device listed
- July 20, 2026
- Registered through
- 2026
- Brand names listed
- GYNECARE TVT ABBREVO Continence System, GYNECARE TVT ABBREVO Continence System and Passers and Winged Guide, GYNECARE TVT EXACT CONTINENCE SYSTEM, GYNECARE TVT EXACT Continence System, GYNECARE TVT EXACT Continence System Trocar, GYNECARE TVT EXACT Continence System and Trocar, GYNECARE TVT Tension-Free Vaginal Tape System, GYNECARE TVT Abdominal Guides and Couplers and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence | PWJ | 2 | Specification developer | accessdata.fda.gov |
| Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator | OTN | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 17, 2020 | K201686 | GYNECARE TVT System, GYNECARE TVT with Abdominal Guides System, GYNECARE TVT Introducer and Catheter Guide, GYNECARE TVT EXACT Continence System and Trocar, GYNECARE TVT Obturator System and Passers and Winged Guide, GYNECARE TVT ABBREVO Continence System and Passers and Winged Guide | OTN | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| August 10, 2018 | K181151 | GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System | PWJ | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| July 6, 2018 | K173019 | GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar | PWJ | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| June 28, 2018 | K173162 | GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide | PWJ | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| August 23, 2013 | K132054 | GYNECARE TVT EXACT CONTINENCE SYSTEM | OTN | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| July 1, 2010 | K100936 | GYNECARE TVT ABBREVO CONTINENCE SYSTEM | OTN | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| March 16, 2010 | K100485 | GYNECARE TVT EXACT CONTINENCE SYSTEM | OTN | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| December 8, 2003 | K033568 | GYNECARE TVT OBTURATOR SYSTEM | OTN | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| October 26, 2001 | K012628 | GYNECARE TENSION-FREE VAGINAL TAPE SYSTEM | OTN | Substantially Equivalent | Gynecare Center | accessdata.fda.gov |
Compare with other makers
- All makers of Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
- All makers of Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence
Updated September 17, 2020. 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.