FDA.reportPublic FDA data

Suction and irrigation Pump for Laparoscopy

Primary DI
04056702000622
Brand
Suction and irrigation Pump for Laparoscopy
Company
W.O.M. World of Medicine GmbH
Model
P101
Published
2016-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HETLaparoscope, Gynecologic (And Accessories)

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K990732000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K990732000LAP-WAVE 3000 (P07)W.O.M. World of Medicine GmbH1999-07-23HET

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04056702000622PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056702000622040567020006224056702000622

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic irrigation/aspiration pumpA mains electricity (AC-powered) device intended to generate positive and/or negative pressures, to irrigate and/or aspirate a body cavity or lumen with sterile fluid (e.g., saline water) through an endoscope typically to facilitate observation of a site with an endoscope (e.g., during arthroscopy), and/or to keep clear the working channel of an endoscope or lumen of a catheter.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
316305242
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04056702012007Tube set for irrigation, single-useTS-P106-A2842302026-03-10
04056702012021Tube set for suction, 2-lines, single-useTS-P107-A2842312026-03-10
04056702012045Day use tube set for irrigation, pump part, 10 applicationsTS-P508-A2842322026-03-10
04056702012069Patient tube for irrigation, single-useTS-P508-A2842332026-03-10
04056702012083Tube set for vacuum, incl. filter, 30-day useTS-P501-C2842352026-03-10
04056702012106Tube set for suction, single-useTS-P102-H2842362026-03-10
04056702012120Tube set inflow 4-Spike adaptorTS-P502-A2842342026-03-10
04056702011970PUREVUE™ FMSPA1242842262026-03-10
04056702011987Autoclavable remote controlB022842272026-03-10
04056702011994Double pedal foot switchPZ3002842282026-03-10
04056702012014Tube set for irrigation, single-useTS-P106-A2026-03-10
04056702012038Tube set for suction, 2-lines, single-useTS-P107-A2026-03-10
04056702012052Day use tube set for irrigation, pump part, 10 applicationsTS-P508-A2026-03-10
04056702012076Patient tube for irrigation, single-useTS-P508-A2026-03-10
04056702012090Tube set for vacuum, incl. filter, 30-day useTS-P501-C2026-03-10
04056702012113Tube set for suction, single-useTS-P102-H2026-03-10
04056702012137Tube set inflow 4-Spike adaptorTS-P502-A2026-03-10
04056702012861GYN-PumpPH3042024-06-28
04056702012878Fluid Monitoring UnitPS3042024-06-28
04056702001544HEATED HUMIDIFIED TUBE SET06200503002017-05-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10653405044703CORE DYNAMICSConmed CorporationHET2026-03-23
10887482155261Symmetry Secto®ASPEN SURGICAL PRODUCTS, INC.HET2024-09-09
10887482155285Symmetry Secto®ASPEN SURGICAL PRODUCTS, INC.HET2024-09-09
10887482155308Symmetry Secto®ASPEN SURGICAL PRODUCTS, INC.HET2024-09-09
10887482155322Symmetry Secto®ASPEN SURGICAL PRODUCTS, INC.HET2024-09-09
10381780538608Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538622Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538646Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538660Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538677Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538691Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538707Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538714Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538721Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538776MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538783MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538790Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538806Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538813Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538837MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538844MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538851Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538899Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538905Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538936Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538943Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538950Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780539001Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780539056Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780539063Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29