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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04066524011683Arthroscope Ø 2.7 mm, 0°, 140 mm, autoclavableXION GmbHHRX2026-09-25
04066524011690Arthroscope Ø 2.7 mm, 30°, 140 mm, autoclavableXION GmbHHRX2026-09-25
04066524011706Arthroscope Ø 2.7 mm, 70°, 140 mm, autoclavableXION GmbHHRX2026-09-25
04066524011713HD3 Arthroscope Ø 4 mm, 0°,185 mm, autoclavableXION GmbHHRX2026-09-25
04066524011720HD3 Arthroscope Ø 4 mm, 30°, 185 mm, autoclavableXION GmbHHRX2026-09-25
04066524011737HD3 Arthroscope Ø 4 mm, 45°, 185 mm, autoclavableXION GmbHHRX2026-09-25
04066524011744HD3 Arthroscope Ø 4 mm, 70°, 185 mm, autoclavableXION GmbHHRX2026-09-25
08809695579813Trocar Needle (Working Channel)GS Medical Co., Ltd.HRX2026-07-27
08809695579820Bevel Needle (Working Channel)GS Medical Co., Ltd.HRX2026-07-27
00190776422059MillenniumAvalign Technologies, Inc.HRX2026-07-24
00190776422066MillenniumAvalign Technologies, Inc.HRX2026-07-24
10810004821085Spinal Needle SetCLARUS MEDICAL, LLCHRX2026-06-23
10810004821146Curved Cannula SetCLARUS MEDICAL, LLCHRX2026-06-23
00810004821101Digital SpineScope EndoscopeCLARUS MEDICAL, LLCHRX2026-06-22
10810004821122Spinal Introducer SetCLARUS MEDICAL, LLCHRX2026-06-22
00846338001209IEC BiPolar Cable, DisposableELLIQUENCE, LLCHRX2026-06-03
00846338001230Bipolar CableELLIQUENCE, LLCHRX2026-06-03
00846338001247Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCHRX2026-06-03
00846338001537Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCHRX2026-06-03
00846338001582IEC Power Cord 110vELLIQUENCE, LLCHRX2026-06-03
00846338001605IEC Power Cord 220v ANZ PlugELLIQUENCE, LLCHRX2026-06-03
00846338001612IEC Power Cord 220v EuropeELLIQUENCE, LLCHRX2026-06-03
00846338001629IEC Power Cord U.K. 220vELLIQUENCE, LLCHRX2026-06-03
00846338007140BiPolar Cable, DisposableELLIQUENCE, LLCHRX2026-06-02
00846338005146Neutral PlateELLIQUENCE, LLCHRX2026-06-01
00846338005320Needle PunchELLIQUENCE, LLCHRX2026-06-01
10845854035559E9000Conmed CorporationHRX2026-03-24
07613327601695Connected OR HubSTRYKER CORPORATIONHRX2025-06-04
07613327601701SDC4K Information Management SystemSTRYKER CORPORATIONHRX2025-06-04
07613327638226OmnicurveSTRYKER CORPORATIONHRX2024-09-03