CALDERA MEDICAL, INC.

FDA Device Registration & Listing · Westlake Village, CA, US · Registration 3003990090

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3003990090
FEI Number
3003990090
Entity Name
CALDERA MEDICAL, INC.
City/State/Country
Westlake Village, CA, US
Establishment Address
4360 Park Terrace Drive, Westlake Village, CA 91361, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Caldera Medical (Owner Number: 10028052)
Owner / Operator Contact Address
4360 Park Terrace Drive, Westlake Village, CA 91361, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K181909
PMA Number
N/A

All Registered Proprietary Names

Benesta Max Tissue Removal Device, 1/BX Benesta Tissue Removal Device, 3 pk Benesta Pro Tissue Removal Device, 1/BX + Outflow Tubing, 1/BX Benesta Max Tissue Removal Device, 1/BX + Outflow Tubing, 1/BX Benesta Tissue Removal Device, 1 pk Benesta Pro Tissue Removal Device, 1/BX Benesta Outflow Tubing, 10/BX Benesta Plus Tissue Removal Device, 1/BX Benesta Plus Tissue Removal Device, 1/BX + Outflow Tubing, 1/BX Benesta Outflow Tubing, 1/BX Vertessa Lite Y-Mesh Desara TVez 2.7mm Desara TVez 3mm Desara Blue TVez 2.7mm Desara Blue TVez 3mm Desara Desara Blue LUMINELLE DTx Hysteroscopy System Caldera Medical Surgical Mesh Instruments GYNECARE TVT™ Reusable Introducer, Reusable Rigid Catheter Guide, GYNECARE TVT EXACT™ Continence System Trocar GYNECARE TVT EXACT™ Continence System Desara SL Benesta Tissue Removal Device Benesta Hysteroscope GYNECARE TVT ABBREVO™ Continence System Desara Blue SS Desara Blue OV Desara TV and Desara Blue TV Innovo Benesta Steririlization Tray GYNECARE TVT™ Abdominal Guides and Couplers, Reusable Introducer, Reusable Rigid Catheter Guide Desara One Single Incision Sling GYNECARE TVT™ Obturator Device GYNECARE TVT ABBREVO™ and GYNECARE TVT™ Obturator Helical Passers and Atraumatic Winged Guide Vertessa Lite LUMINELLE DTx System Luminelle DTx Hysteroscopy System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2024-04-03
OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed General, Plastic Surgery Class 2 878.3300 2015-07-07
PWJ Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence Obstetrics/Gynecology Class 2 884.4910 2021-11-12
OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator General, Plastic Surgery Class 2 878.3300 2021-11-12
OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator General, Plastic Surgery Class 2 878.3300 2013-12-06
FAJ Cystoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2025-01-09
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2025-01-09
PWJ Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence Obstetrics/Gynecology Class 2 884.4910 2018-05-21
PWJ Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence Obstetrics/Gynecology Class 2 884.4910 2025-06-30
OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator General, Plastic Surgery Class 2 878.3300 2025-06-30
OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator General, Plastic Surgery Class 2 878.3300 2013-03-04
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2020-11-16
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2020-09-21
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2020-09-21
OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator General, Plastic Surgery Class 2 878.3300 2025-06-30
OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator General, Plastic Surgery Class 2 878.3300 2014-12-08
OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator General, Plastic Surgery Class 2 878.3300 2017-01-13
QAJ Cutaneous Electrode Stimulator For Urinary Incontinence Gastroenterology, Urology Class 2 876.5330 2024-12-19
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2020-08-06
OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator General, Plastic Surgery Class 2 878.3300 2025-06-30
PWJ Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence Obstetrics/Gynecology Class 2 884.4910 2025-06-30
PWJ Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence Obstetrics/Gynecology Class 2 884.4910 2020-02-11
PAH Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling General, Plastic Surgery Class 2 878.3300 2020-02-11
OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator General, Plastic Surgery Class 2 878.3300 2025-06-30
PWJ Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence Obstetrics/Gynecology Class 2 884.4910 2025-06-30
OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed General, Plastic Surgery Class 2 878.3300 2015-07-07
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2025-01-09
FAJ Cystoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2025-01-09
FAJ Cystoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2025-01-09
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2025-01-09

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Caldera Medical
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K935716 KARL STORZ Endoscopy-America, Inc. KARL STORZ FIXED MAGNIFICATION TELESCOPE/KS VARIABLE MAGNIFICATION TELESCOPE 1995-11-16
K222293 Urocure, LLC ArcSP Suprapubic Sling System 2022-09-21
K243425 Talladium España, SL Guided DAS Surgical Kit 2025-07-22
K213209 K1 Medical, LLC EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device 2021-12-28
K012105 Symmetry Medical, Inc. POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM 2002-08-02

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003990090. Last updated year: 2026. Please use registration number 3003990090 when referencing this establishment in official correspondence.
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