FDA.reportPublic FDA data

Benesta Hysteroscope Set

Primary DI
00857492008041
Brand
Benesta Hysteroscope Set
Company
Caldera Medical, Inc.
Model
CAL-TR111
Device description
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
Published
2022-08-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HIHHysteroscope (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIHHysteroscope (And Accessories)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192822000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192822000Benesta HysteroscopeCaldera Medical, Inc.2020-09-09HIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857492008041PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857492008041008574920080418574920080410857492008041

GMDN Terms#

Term, Definition table
TermDefinition
Rigid optical hysteroscopeAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the canal of the cervix and the uterine cavity (uterus). It is inserted through the vagina during hysteroscopy. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. Distention of the uterus with, e.g., carbon dioxide(CO2) gas may be used to improve viewing. This device is commonly used to evaluate/treat fibroids (myomas), polyps, or causes of severe cramping (dysmenorrhea), heavy menstrual periods (menorrhagia), and bleeding between periods (metrorrhagia). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter5.8Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature, in clean and dry location

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""High-level Disinfectant"", ""Liquid Chemical""]"
Moist Heat or Steam Sterilization;High-level Disinfectant;Liquid Chemical

Contacts#

Phone, Email table
PhoneEmail
1-818-879-6555hello@calderamedical.com

Regulatory Flags#

DUNS number
130341956
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857492008164Benesta Hysteroscope Adapter CAL-TR14312022-07-19
00890594000124Desara Blue TVez 3.0CAL-DS01BTV302022-08-03
00890594000131Desara TVez 2.7CAL-DS01TV272022-08-03
00890594000155Desara TVez 3.0CAL-DS01TV302022-08-03
00890594000193Desara Blue TVez 2.7CAL-DS01BTV272022-08-03
00890594000087Desara Blue TVez 3.0CAL-DS01BTV302021-11-15
00890594000094Desara Blue TVez 2.7CAL-DS01BTV272021-11-15
00890594000100Desara TVez 2.7CAL-DS01TV272021-11-15
00890594000117Desara TVez 3.0CAL-DS01TV302021-11-15
00890594000230Transvaginal 4.0 mm IntroducerCAL-TV02CAL-TV022019-09-30
00890594000865Transvaginal 3.2 mm IntroducerCAL-TV32CAL-TV322019-09-30
00890594000933Transobturator Inside-Out, Right 3.2 mm IntroducerCAL-IOR32CAL-IOR322019-11-05
00890594000940Transobturator Inside-Out, Left 3.2 mm IntroducerCAL-IOL32CAL-IOL322019-11-05
00890594000018Transobturator Helical, Left IntroducerCAL-HL04CAL-HL042019-09-30
00890594000148Transobturator Helical, Right IntroducerCAL-HR05CAL-HR052019-09-30
00890594000162Transobturator Large Helical, Left IntroducerCAL-LHL1CAL-LHL12019-09-30
00890594000179Transobturator Large Helical, Right IntroducerCAL-LHR2CAL-LHR22019-09-30
00890594000186Transobturator Inside-Out, Left IntroducerCAL-IO6CAL-IO62019-09-30
00890594000209Transobturator Inside-Out, Right IntroducerCAL-IO7CAL-IO72019-09-30
00890594000216Transobturator Hook IntroducerCAL-TB03CAL-TB032019-09-30

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Primary DI, Brand, Company table
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