FDA.reportPublic FDA data

Surgical fluid/gas irrigator

Definition
A 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.
GUDID devices
70
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00803622104060Surgical irrigatorLIVANOVA USA, INC.MT-xxxxx2015-07-13
00803622104077Surgical irrigatorLIVANOVA USA, INC.MT-xxxxx2015-07-13
00803622104084Surgical irrigatorLIVANOVA USA, INC.MT-xxxxx2015-07-13
00803622106644Surgical irrigatorLIVANOVA USA, INC.MT-xxxxx2015-07-13
00803622128110Surgical irrigatorLIVANOVA USA, INC.MT-xxxxx2015-09-17
00848340002052UNBRANDEDADVANCE MEDICAL DESIGNS, INC.72-CFS012016-09-21
00848340002069UNBRANDEDADVANCE MEDICAL DESIGNS, INC.72-CFS022016-09-21
00848340007187UNBRANDEDADVANCE MEDICAL DESIGNS, INC.65-CMS042016-09-21
00848340008450UNBRANDEDADVANCE MEDICAL DESIGNS, INC.65-CMS032016-09-21
00848340008559UNBRANDEDADVANCE MEDICAL DESIGNS, INC.64-CMS022016-09-21
00848340009204UNBRANDEDADVANCE MEDICAL DESIGNS, INC.CFS01NS2016-09-21
00848340009211UNBRANDEDADVANCE MEDICAL DESIGNS, INC.CFS02NS2016-09-21
00848340009228UNBRANDEDADVANCE MEDICAL DESIGNS, INC.CMS02NS2016-09-21
00848340009235UNBRANDEDADVANCE MEDICAL DESIGNS, INC.CMS03NS2016-09-21
00848340009242UNBRANDEDADVANCE MEDICAL DESIGNS, INC.CMS04NS2016-09-21
00848340019432Closed Monitoring SystemADVANCE MEDICAL DESIGNS, INC.64-CMS032023-06-08
00848340019449Closed Fluid SystemADVANCE MEDICAL DESIGNS, INC.64-CMS042023-06-08
00878799008077SURGISTARSURGISTAR, INC.5010302016-08-02
10848340019439Closed Monitoring SystemADVANCE MEDICAL DESIGNS, INC.64-CMS032023-06-08
10848340019446Closed Fluid SystemADVANCE MEDICAL DESIGNS, INC.64-CMS042023-06-08
00842331174520Novo Surgical Inc. NOVO SURGICAL, INC.OP7122-942022-11-14
00842331175602Novo Surgical Inc. NOVO SURGICAL, INC.OP7121-982022-11-14
00842331175633Novo Surgical Inc. NOVO SURGICAL, INC.OP7123-222022-11-14
00842331175657Novo Surgical Inc. NOVO SURGICAL, INC.OP7124-992022-11-14
00842331177255Novo Surgical Inc. NOVO SURGICAL, INC.OP7122-042022-11-14
00842331181795Novo Surgical Inc. NOVO SURGICAL, INC.OP7123-662022-11-14
00842331189203Novo Surgical Inc. NOVO SURGICAL, INC.NSE4421H-12022-11-14
00842331189210Novo Surgical Inc. NOVO SURGICAL, INC.OP7122-912022-11-14
00842331145599Novo Surgical Inc. NOVO SURGICAL, INC.OP7122-592022-11-11
00842331146046Novo Surgical Inc. NOVO SURGICAL, INC.OP7122-962022-11-11
00842331152900Novo Surgical Inc. NOVO SURGICAL, INC.OP7123-212022-11-12
00842331158667Novo Surgical Inc. NOVO SURGICAL, INC.OP7123-232022-11-12
00842331159428Novo Surgical Inc. NOVO SURGICAL, INC.OP7122-802022-11-13
00842331164972Novo Surgical Inc. NOVO SURGICAL, INC.OP7122-502022-11-13
00842331169939Novo Surgical Inc. NOVO SURGICAL, INC.OP7122-032022-11-13
00842331133794Novo Surgical Inc. NOVO SURGICAL, INC.OP7122-982022-11-10
04961333240791N/APENTAX OF AMERICA, INC.670772018-02-28
04961333240807N/APENTAX OF AMERICA, INC.670782018-02-28
04961333240814N/APENTAX OF AMERICA, INC.670792018-02-28
04961333240821N/APENTAX OF AMERICA, INC.670802018-02-28
04961333240838N/APENTAX OF AMERICA, INC.670812018-02-28
04961333241224N/APENTAX OF AMERICA, INC.841102018-03-01
04961333241262N/APENTAX OF AMERICA, INC.863372018-03-02
04961333241279N/APENTAX OF AMERICA, INC.863452018-03-02
04961333241699N/APENTAX OF AMERICA, INC.100110P2018-03-06
04961333241705N/APENTAX OF AMERICA, INC.100125P2018-03-13
04961333241729IRRIGATOR/INSUFFLATORPENTAX OF AMERICA, INC.100130P2018-03-13
04961333241736N/APENTAX OF AMERICA, INC.100135P2018-03-13
04961333241743N/APENTAX OF AMERICA, INC.100136P2018-03-13
04961333241873N/APENTAX OF AMERICA, INC.200230P2018-03-13
04961333241880N/APENTAX OF AMERICA, INC.200270P2018-03-06
04961333242924IRRIGATOR/INSUFFLATORPENTAX OF AMERICA, INC.EGA-500P2018-03-12
04961333242993IRRIGATOR/INSUFFLATORPENTAX OF AMERICA, INC.EGA-70162018-03-12
04961333243037ENDO-GATORPENTAX OF AMERICA, INC.EGP-100P2018-03-12
10848340002059UNBRANDEDADVANCE MEDICAL DESIGNS, INC.72-CFS012016-09-21
10848340002066UNBRANDEDADVANCE MEDICAL DESIGNS, INC.72-CFS022016-09-21
10848340007184UNBRANDEDADVANCE MEDICAL DESIGNS, INC.65-CMS042016-09-21
10848340008457UNBRANDEDADVANCE MEDICAL DESIGNS, INC.65-CMS032016-09-21
10848340008556UNBRANDEDADVANCE MEDICAL DESIGNS, INC.64-CMS022016-09-21
10848340009201UNBRANDEDADVANCE MEDICAL DESIGNS, INC.CFS01NS2016-09-21
10848340009218UNBRANDEDADVANCE MEDICAL DESIGNS, INC.CFS02NS2016-09-21
10848340009225UNBRANDEDADVANCE MEDICAL DESIGNS, INC.CMS02NS2016-09-21
10848340009232UNBRANDEDADVANCE MEDICAL DESIGNS, INC.CMS03NS2016-09-21
10848340009249UNBRANDEDADVANCE MEDICAL DESIGNS, INC.CMS04NS2016-09-21
10878799008074SURGISTARSURGISTAR, INC.5010302016-08-02
10803622104067Surgical irrigatorLIVANOVA USA, INC.MT-xxxxx2015-07-13
10803622104074Surgical irrigatorLIVANOVA USA, INC.MT-xxxxx2015-07-13
10803622104081Surgical irrigatorLIVANOVA USA, INC.MT-xxxxx2015-07-13
10803622106641Surgical irrigatorLIVANOVA USA, INC.MT-xxxxx2015-07-13
10803622128117Surgical irrigatorLIVANOVA USA, INC.MT-xxxxx2015-09-17