FDA.reportPublic FDA data

CALDERA MEDICAL, INC.

Matched from indexed company URL: CALDERA MEDICAL

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30039900903003990090CALDERA MEDICAL, INC.1N2026-01-014360 Park Terrace Drive Westlake Village CA US 91361

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00857492008164Benesta Hysteroscope Adapter - The Benesta Hysteroscope Adapter is placed between non-Caldera Medical hysteroscopes and the Benesta Tissue Removal Device (TRD) to properly position the TRD while in use.1-818-879-6555hello@calderamedical.com
00890594000087Desara Blue TVez 3.0 - Desara Blue TVez 3.0mm for the treatment of female stress urinary incontinence (SUI) or mixed incontinence1-866-422-5337info@calderamedical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
977131511544323K233500Benesta Tissue Removal DeviceHIH2023-11-30
977131016921851K211975Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 SystemOTN2021-11-10
977131844209350K210512LUMINELLE DTx SystemFAJ2021-06-30
977131818641404K201686GYNECARE 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 GuideOTN2020-09-17
977131278789083K193603Benesta Medical Sterilization TrayKCT2020-07-20
977131791991541K192822Benesta HysteroscopeHIH2020-09-09
977131136948728K192811BenestaTM Tissue Removal DeviceHIH2020-10-23
977131343437967K192357INNOVOQAJ2020-01-16
977131487064013K192278Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic)HIH2019-11-01
977131790474224K191416Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 PackPAH2020-02-07
977131474173700K190827Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath RigidHIH2019-06-06
977131731028534K181909Luminelle DTx Hysteroscopy SystemFAJ2018-08-16
977131232099203K181151GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence SystemPWJ2018-08-10
977131112191874K173162GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter GuidePWJ2018-06-28
977131876997769K173019GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System TrocarPWJ2018-07-06
977131810890312K172614Caldera 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, LeftPWJ2018-05-04
977131836077860K162201Desara TV, Desara Blue TVOTN2017-01-11
977131509759146K150023Vertessa Lite Y-MeshOTO2015-04-06
977131196294438K150016Vertessa LiteOTO2015-04-06
977132055286683K140843DESARA BLUE OV, DESARA BLUE SSOTN2014-07-01
977131933586987K132069DESARA MESH, DESARA BLUEOTN2013-09-23
977131245883911K132054GYNECARE TVT EXACT CONTINENCE SYSTEMOTN2013-08-23
977131299772820K123337VERTESSA LITE 10 X 20CM, VERTESSA LITE 11 X 30CMOTO2013-02-21
977131052822047K123028VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESHOTO2013-04-25
977131467434591K121928DESARA SLOTN2013-02-19
977131261984859K120327VERTESSAOTO2012-05-10
977131724461029K112609DESARA MESHOTN2011-09-30
977131956373314K101169DESARA MESH MODEL: CAL-DS01OTN2010-05-20
977131816492447K100936GYNECARE TVT ABBREVO CONTINENCE SYSTEMOTN2010-07-01
977131977883065K100485GYNECARE TVT EXACT CONTINENCE SYSTEMOTN2010-03-16
977131110516600K072456DESARA MESH SLING, MODEL CAL-DS01OTN2008-05-08
977132069396580K033568GYNECARE TVT OBTURATOR SYSTEMOTN2003-12-08

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OTN132021-11-10
HIH52023-11-30
OTO52015-04-06
PWJ42018-08-10
FAJ22021-06-30
KCT12020-07-20
PAH12020-02-07
QAJ12020-01-16

PMN#

ASCEND

2009-03-31

CALDERA MEDICAL, INC.

POPMESH

2006-02-22

CALDERA MEDICAL, INC.

GUDID#

Benesta Hysteroscope Set - Benesta Rod Lens Hysteroscope for viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and operative/surgical procedures. The Set contains: CAL-TR113 Benesta Hysteroscope CAL-TR112 Benesta Outflow Channel CAL-TR121 Benesta Hysteroscope Light Source Adapter (Storz/Olympus) CAL-TR122 Benesta Hysteroscope Light Source Adapter (Dyonics/Wolf) CAL-TR123 Benesta Stopcock Lever and Cap (2 each) CAL-TR124 Benesta Hysteroscope/Outflow Channel End Cap (2 each) CAL-TR125 Benesta Working Channel Brush, 3mm CAL-TR126 Benesta Inflow Channel Brush, 2mm

Caldera Medical, Inc.

2022-08-03

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