Caldera Medical, Inc.
Westlake Village, CA, US
CALDERA MEDICAL, INC. appears in FDA device records in Westlake Village, CA. FDA records list 24 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 24 510(k) clearances for Caldera Medical, Inc. between 2006 and 2023. The busiest year on record is 2013, with 4. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 2 |
| 2008 | 1 |
| 2009 | 1 |
| 2010 | 2 |
| 2011 | 2 |
| 2012 | 1 |
| 2013 | 4 |
| 2014 | 1 |
| 2015 | 2 |
| 2017 | 1 |
| 2018 | 1 |
| 2020 | 4 |
| 2021 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K233500 | Benesta Tissue Removal Device | HIH | Substantially Equivalent | |
| K211975 | Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System | OTN | Substantially Equivalent | |
| K192811 | BenestaTM Tissue Removal Device | HIH | Substantially Equivalent | |
| K192822 | Benesta Hysteroscope | HIH | Substantially Equivalent | |
| K193603 | Benesta Medical Sterilization Tray | KCT | Substantially Equivalent | |
| K191416 | Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack | PAH | Substantially Equivalent | |
| K172614 | 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 | PWJ | Substantially Equivalent | |
| K162201 | Desara TV, Desara Blue TV | OTN | Substantially Equivalent | |
| K150023 | Vertessa Lite Y-Mesh | OTO | Substantially Equivalent | |
| K150016 | Vertessa Lite | OTO | Substantially Equivalent | |
| K140843 | DESARA BLUE OV, DESARA BLUE SS | OTN | Substantially Equivalent | |
| K132069 | DESARA MESH, DESARA BLUE | OTN | Substantially Equivalent | |
| K123028 | VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH | OTO | Substantially Equivalent | |
| K123337 | VERTESSA LITE 10 X 20CM, VERTESSA LITE 11 X 30CM | OTO | Substantially Equivalent | |
| K121928 | DESARA SL | OTN | Substantially Equivalent | |
| K120327 | VERTESSA | OTO | Substantially Equivalent | |
| K103418 | DESARA MINI | PAH | Substantially Equivalent | |
| K112609 | DESARA MESH | OTN | Substantially Equivalent | |
| K101462 | ASCEND BLUE AC MESH; ASCEND BLUE PC MESH | FTL | Substantially Equivalent | |
| K101169 | DESARA MESH MODEL: CAL-DS01 | OTN | Substantially Equivalent | |
| K083722 | ASCEND | OTP | Substantially Equivalent | |
| K072456 | DESARA MESH SLING, MODEL CAL-DS01 | OTN | Substantially Equivalent | |
| K060004 | CALDERA MESH | FTL | Substantially Equivalent | |
| K053424 | POPMESH | FTL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003990090 | 3003990090 | CALDERA MEDICAL, INC. | 4360 Park Terrace Drive, Westlake Village, CA 91361 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- QAJCutaneous Electrode Stimulator For Urinary Incontinence
- FAJCystoscope And Accessories, Flexible/Rigid
- HIHHysteroscope (And Accessories)
- PWJInstrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence
- FTLMesh, Surgical, Polymeric
- OTOMesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
- OTPMesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
- PAHMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
- OTNMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain