FDA.reportPublic FDA data

IRRIGATOR/INSUFFLATOR

Primary DI
04961333241729
Brand
IRRIGATOR/INSUFFLATOR
Company
PENTAX OF AMERICA, INC.
Model
100130P
Device description
IRRIG TUBING, EGA-500P, 10/PKG
Published
2018-03-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Product Codes#

Code, Name table
CodeName
FEQPump, Air, Non-Manual, For Endoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FEQPump, Air, Non-Manual, For EndoscopeGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092429000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092429000ENDOGATORByrne Medical, Inc.2009-11-19FEQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04961333241729PrimaryGS10
14961333241726Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04961333241729049613332417294961333241729
1496133324172614961333241726

GMDN Terms#

Term, Definition table
TermDefinition
Surgical fluid/gas irrigatorA sterile, hand-operated surgical device intended for the controlled delivery of medical gas and fluid (e.g., saline solution) to an open surgical site to improve visibility, by clearing bloody fluids/debris, and to prevent tissue desiccation. It is typically made of plastic materials [e.g., polypropylene, polyvinyl chloride (PVC)] and may be double-lumen for nebulization of fluid/gas, or dual-line for separate fluid and gas administration and include an antibacterial filter. It typically includes a nozzle at the distal end and connector(s) [e.g., Luer] at the proximal end for connection to the fluid/gas sources; a manual tubing clamp may also be included. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
083211284
Device count
10
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854924006255C2 CryoBalloon Ablation System FG-10252025-04-04
00854924006293C2 CryoBalloon Ablation SystemFG-10292025-04-04
04961333255313C2 CryoBalloonFG-10552024-09-12
04961333255320C2 CryoBalloonFG-10562024-09-12
04961333248445C2 CryoBalloon NitroclipFG-10502020-08-07
00854924006408C2 CryoBalloon EndoGripFG-10402020-07-29
04961333232550ULTRASOUND GASTROSCOPEEG-3670URK2017-04-06
04961333232567ULTRASOUND GASTROSCOPEEG-3870UTK2017-04-06
04961333233953ULTRASOUND GASTROSCOPEEG-3270UK2017-06-26
04961333231942VIDEO PROCESSOREPK-I5010-US2018-04-16
04961333232598VIDEO PROCESSOREPK-I50102017-04-06
04961333232604VIDEO PROCESSOREPK-I70102017-04-06
04961333242207N/A92026/102018-03-08
04961333242214N/A92026/252018-03-08
04961333242221N/A92026/32018-03-08
04961333242238N/A92026/502018-03-08
04961333242276N/A92052/202018-03-08
04961333242283N/A92052/62018-03-08
04961333242306N/A92092/122018-03-08
04961333242313N/A92092/252018-03-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M710TCW51000Bayou™ troCarWash System Disposable KitBIOTEX, INC.FEQ2025-10-10
00191506038885HydraBOSTON SCIENTIFIC CORPORATIONFEQ2024-10-07
00191506038892HydraBOSTON SCIENTIFIC CORPORATIONFEQ2024-10-07
M710TCW101200Bayou™ troCarWash System Disposable KitBIOTEX, INC.FEQ2024-01-31
M710TCWC0Bayou™ troCarWash System ControllerBIOTEX, INC.FEQ2024-01-22
00724995228903DEFENDOMEDIVATORS INC.FEQ2024-01-18
00724995228910DEFENDOMEDIVATORS INC.FEQ2024-01-18
00724995228927DEFENDOMEDIVATORS INC.FEQ2024-01-18
00724995228934DEFENDOMEDIVATORS INC.FEQ2024-01-18
00724995228941DEFENDOMEDIVATORS INC.FEQ2024-01-18
00724995228958DEFENDOMEDIVATORS INC.FEQ2024-01-18
00724995228965DEFENDOMEDIVATORS INC.FEQ2024-01-18
50724995228908DEFENDOMEDIVATORS INC.FEQ2024-01-18
50724995228922DEFENDOMEDIVATORS INC.FEQ2024-01-18
50724995228946DEFENDOMEDIVATORS INC.FEQ2024-01-18
00724995227340NAUS EndoscopyFEQ2023-11-13
04065655000436ERBEFLO CleverCap®Erbe Medical, LLCFEQ2023-09-22
04065655000689ERBEFLO CleverCap®Erbe Medical, LLCFEQ2023-09-22
04065655000887ERBEFLO CleverCap®Erbe Medical, LLCFEQ2023-09-22
04065655000917ERBEFLO CleverCap®Erbe Medical, LLCFEQ2023-09-22
04065655000948ERBEFLO AeroRinse®Erbe Medical, LLCFEQ2023-09-22
04065655000979ERBEFLO AeroRinse®Erbe Medical, LLCFEQ2023-09-22
04065655001006ERBEFLO CleverCap®Erbe Medical, LLCFEQ2023-09-22
04065655001037ERBEFLO AeroRinse®Erbe Medical, LLCFEQ2023-09-22
04065655001068ERBEFLO AeroRinse®Erbe Medical, LLCFEQ2023-09-22
04065655001099ERBEFLO CleverCap®Erbe Medical, LLCFEQ2023-09-22
04065655000375ERBEFLO CleverCap®Erbe Medical, LLCFEQ2023-09-22
04065655000405ERBEFLO CleverCap®Erbe Medical, LLCFEQ2023-09-22
04065655000825ERBEFLO CleverCap®Erbe Medical, LLCFEQ2023-09-22
04065655000863ERBEFLO CleverCap®Erbe Medical, LLCFEQ2023-09-22