FDA.reportPublic FDA data

HydroCision Console

Primary DI
00853235007043
Brand
HydroCision Console
Company
HYDROCISION, INC.
Model
52700
Catalog number
52700
Device description
HydroCision Console
Published
2017-08-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HRXArthroscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K002764000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002764000HYDROCISION ARTHROJET SYSTEM WITH CAUTERY AND BURRHydrocision, Inc.2000-11-24HRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853235007043PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853235007043008532350070438532350070430853235007043

GMDN Terms#

Term, Definition table
TermDefinition
Water jet knife system generatorA mains electricity (AC-powered) device that is a component of a water jet knife system and that generates and regulates a stream of high-pressure water to cut/dissect soft tissues, leaving hard/elastic tissues intact. The pressurized water (typically sterile saline) is delivered to the surgical site via a dedicated handpiece. The operator will typically regulate the stream of water for cutting with a foot-switch connected to the generator.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
834612764
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853235007005TenJet® 76000760002018-05-22
00853235007012TenJet®76400764002017-08-21
00853235007029TenJet®76700767002017-08-21
00853235007067SpineJet®56000560002017-08-25
00853235007326SpineJet® PerResector-China Version56000560002017-08-21
00853235007333HydroCision Console82700827002023-11-14
00853235007036SpineJet® 52320523202017-08-21
00853235007050SpineJet®55500555002017-08-21
00853235007074SpineJet®56110561102017-08-21
00853235007081SpineJet®56971569712017-08-21
00853235007098SpineJet®56986569862017-08-21
00853235007104SpineJet® 56987569872017-08-21
00853235007111SpineJet®57162571622017-08-21
00853235007128SpineJet®57167571672017-08-21
00853235007135SpineJet® 57662576622017-08-21
00853235007142SpineJet®57667576672017-08-21
00853235007159SpineJet® 58162581622017-08-21
00853235007166SpineJet® 58163581632017-08-21
00853235007173SpineJet®58662586622017-08-21
00853235007180SpineJet®58663586632017-08-21

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