FDA.reportPublic FDA data

Aveta Controller

Primary DI
00850006759019
Brand
Aveta Controller
Company
MEDITRINA, INC.
Model
212-080
Catalog number
212-080
Device description
Aveta Controller
Published
2019-11-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
HIGInsufflator, Hysteroscopic
HIHHysteroscope (And Accessories)

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190372000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190372000Aveta SystemMeditrina, Inc.2019-05-16HIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850006759019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850006759019008500067590198500067590190850006759019

GMDN Terms#

Term, Definition table
TermDefinition
Hysteroscopic irrigation/insufflation systemA mains electricity (AC-powered) device assembly used during endoscopic procedures of the uterus (i.e., hysteroscopy) to distend (expand by pressure) the uterus by filling the uterine cavity with a liquid to improve visualization (e.g., a hysteroscope) and enlarge the surgical field; it also circulates the fluid to provide irrigation that will remove tissue/debris from the site. This system will typically electronically monitor the volume differential between the irrigation fluid flowing into and out of the uterus. Some distention systems are combined with gynaecologic resectoscopes.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080570262
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850006759835Aveta Tissue Catch with Tubing205-2052205-20522026-03-20
00850006759842Aveta Tissue Catch with Tubing205-2052205-20522026-03-20
00850006759811Aveta Drape Pump212-081212-0812025-04-11
00850006759033Aveta Roll Stand with Drape Pump212-205212-2052019-11-26
00850006759699Aveta Waste Management Accessory205-2036205-20362024-10-14
00850006759736Aveta Waste Bag with Tissue Catch205-2037205-20372024-10-14
00850006759705Aveta Waste Management Accessory205-2036205-20362024-10-14
10850006759733Aveta Waste Bag with Tissue Catch205-2037205-20372024-10-14
00850006759460Aveta Smol Disposable Resecting Device, 2.9 mm204-239204-2392024-04-26
00850006759484Aveta Smol Disposable Resecting Device, 2.9 mm204-210204-2102024-04-26
00850006759613Aveta Smol Disposable Resecting Device, 2.9 mm216-2008216-20082024-04-26
00850006759477Aveta Smol Disposable Resecting Device, 2.9 mm204-239204-2392024-04-26
00850006759491Aveta Smol Disposable Resecting Device, 2.9 mm204-210204-2102024-04-26
00850006759620Aveta Smol Disposable Resecting Device, 2.9 mm216-2008216-20082024-04-26
00850006759712Aveta Flex+ Disposable Resecting Device, 2.9 mm210-2011210-20112023-12-01
00850006759729Aveta Max+ Disposable Resecting Device, 3.9 mm210-2013210-20132023-12-01
10850006759719Aveta Flex+ Disposable Resecting Device, 2.9 mm210-2011210-20112023-12-01
10850006759726Aveta Max+ Disposable Resecting Device, 3.9 mm210-2013210-20132023-12-01
00850006759163Aveta Tissue Catch205-259205-2592023-08-16
00850006759224Aveta Tissue Catch205-259205-2592023-08-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850083954154Resectr Resection Device 5FR (1.65 mm)Axora Medical, Inc.HIH2026-09-24
00850083954161Resectr Resection Device 9FR (3.0 mm)Axora Medical, Inc.HIH2026-09-24
00850083954352HERizon RD5 Resecting DeviceAxora Medical, Inc.HIH2026-09-24
06974880994053Manual Tissue Removal DeviceSuzhou AcuVu medical technology Co., Ltd.HIH2026-07-27
06974880994084Manual Tissue Removal DeviceSuzhou AcuVu medical technology Co., Ltd.HIH2026-07-27
06975339623418SeleneView®MacroLux Medical Technology Co., Ltd.HIH2026-07-03
07613327626407ThermaClearSTRYKER CORPORATIONHIG2025-04-04
00821925002104USA Elite SystemGyrus ACMI, LLCHIH2024-11-21
00821925002074USA Elite SystemGyrus ACMI, LLCHIH2024-07-25
00821925002562SlimLineGyrus ACMI, LLCHIH2024-07-24
07613327616675SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616682SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616699SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616705SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616712SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616729SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616736SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616743SPYSTRYKER CORPORATIONHIH2024-02-27
07613327624311NASTRYKER CORPORATIONHIH2024-02-27
07613327507102N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.HIH2020-10-26
07613327507119N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.HIH2020-10-26
07613327507126N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.HIH2020-10-26
07613327507133N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.HIH2020-10-26
07613327507140N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.HIH2020-10-26
08714729986935Cytuity™BOSTON SCIENTIFIC CORPORATIONHIH2019-08-20
10884521750203TruClearCovidien LPHIH2018-12-21
00821925004986Gyrus ACMIGyrus ACMI, LLCHIH2018-09-13
10884521744059NACovidien LPHIG2018-08-31
10884521744066NACovidien LPHIG2018-08-31
10884521744073NACovidien LPHIG2018-08-31