FDA.reportPublic FDA data

Endoscopic-access dilator, single-use

Definition
A device intended to be used to dilate a body lumen or access channel to facilitate the introduction of endoscopic instruments percutaneously (through the skin) or through a natural orifice (e.g., urethra). It may be a flexible or rigid rod/tube with a tapered distal tip. This is a single-use device.
GUDID devices
692
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00699753019027Trocar for Virtuosaph Endoscopied Vein Harvesting SystemTerumo Cardiovascular Systems CorporationMCTRC550S2016-10-11
00699753471009Cardiovascular Procedure KitTerumo Cardiovascular Systems Corporation730772018-08-22
00699753508194Cardiovascular Procedure KitTerumo Cardiovascular Systems Corporation767772018-06-13
00699753508200Cardiovascular Procedure KitTerumo Cardiovascular Systems Corporation767762018-06-13
00699753508378Cardiovascular Procedure KitTerumo Cardiovascular Systems Corporation667242018-07-18
00699753508385Cardiovascular Procedure KitTerumo Cardiovascular Systems Corporation767812018-07-18
00699753508712Cardiovascular Procedure KitTerumo Cardiovascular Systems Corporation768222018-08-22
00699753531130Cardiovascular Procedure KitTerumo Cardiovascular Systems CorporationCX-GE4552024-04-09
00699753531147Cardiovascular Procedure KitTerumo Cardiovascular Systems CorporationCX-NL159X2024-04-09
00699753531154Cardiovascular Procedure KitTerumo Cardiovascular Systems CorporationCX-UK6952024-04-09
00699753531161Cardiovascular Procedure KitTerumo Cardiovascular Systems Corporation77272-012024-04-09
00699753531178Cardiovascular Procedure KitTerumo Cardiovascular Systems CorporationCX-IT611X2024-04-09
00699753531185Cardiovascular Procedure KitTerumo Cardiovascular Systems CorporationCX-IT610X2024-04-10
00699753531215Cardiovascular Procedure KitTerumo Cardiovascular Systems CorporationCX-IT606X2024-04-11
00699753531222Cardiovascular Procedure KitTerumo Cardiovascular Systems Corporation783222024-04-11
00699753531239Cardiovascular Procedure KitTerumo Cardiovascular Systems Corporation783012024-04-11
00699753531246Cardiovascular Procedure KitTerumo Cardiovascular Systems Corporation783002024-04-18
00699753531307Cardiovascular Procedure KitTerumo Cardiovascular Systems Corporation780102024-05-03
00699753531437Cardiovascular Procedure KitTerumo Cardiovascular Systems CorporationCX-CZ205X2024-05-14
00699753531475Cardiovascular Procedure KitTerumo Cardiovascular Systems CorporationCX-CZ2042024-05-28
00699753531482Cardiovascular Procedure KitTerumo Cardiovascular Systems CorporationCX-CZ206X2024-05-28
00699753531499Cardiovascular Procedure KitTerumo Cardiovascular Systems CorporationCX-GE4462024-05-28
00699753531543Cardiovascular Procedure KitTerumo Cardiovascular Systems Corporation783132024-05-29
00699753531598Cardiovascular Procedure KitTerumo Cardiovascular Systems Corporation670172024-05-30
00699753531604Cardiovascular Procedure KitTerumo Cardiovascular Systems CorporationCX-FR3672024-05-31
00699753531819Cardiovascular Procedure KitTerumo Cardiovascular Systems Corporation75001-012024-06-19
00699753531840Cardiovascular Procedure KitTerumo Cardiovascular Systems Corporation782962024-06-25
00699753531857Cardiovascular Procedure KitTerumo Cardiovascular Systems CorporationCX-IT619X2024-06-25
00699753531864Cardiovascular Procedure KitTerumo Cardiovascular Systems CorporationCX-IT6202024-06-25
00699753531871Cardiovascular Procedure KitTerumo Cardiovascular Systems CorporationCX-IT621X2024-06-25
00699753531895Cardiovascular Procedure KitTerumo Cardiovascular Systems Corporation783042024-06-28
00699753531918Cardiovascular Procedure KitTerumo Cardiovascular Systems Corporation781672024-07-02
00699753531925Cardiovascular Procedure KitTerumo Cardiovascular Systems Corporation783062024-07-02
00699753531963Cardiovascular Procedure KitTerumo Cardiovascular Systems Corporation783052024-07-07
00699753532090Cardiovascular Procedure KitTerumo Cardiovascular Systems Corporation783212024-07-10
00699753532175Cardiovascular Procedure KitTerumo Cardiovascular Systems CorporationCX-FR4612024-07-15
00699753532182Cardiovascular Procedure KitTerumo Cardiovascular Systems CorporationCX-FR4622024-07-15
00699753532199Cardiovascular Procedure KitTerumo Cardiovascular Systems CorporationCX-FR4642024-07-15
00699753532243Cardiovascular Procedure KitTerumo Cardiovascular Systems Corporation783692024-07-19
00699753532304Cardiovascular Procedure KitTerumo Cardiovascular Systems Corporation783652024-07-22
00699753532335Cardiovascular Procedure KitTerumo Cardiovascular Systems CorporationCX-FR4602024-07-22
00699753532342Cardiovascular Procedure KitTerumo Cardiovascular Systems CorporationCX-ZA0932024-07-22
00699753532403Cardiovascular Procedure KitTerumo Cardiovascular Systems CorporationCX-SK052X2024-07-25
00699753532410Cardiovascular Procedure KitTerumo Cardiovascular Systems CorporationCX-FR4652024-07-25
00699753532441Cardiovascular Procedure KitTerumo Cardiovascular Systems CorporationCX-LI0162024-08-01
00699753532502Cardiovascular Procedure KitTerumo Cardiovascular Systems Corporation783622024-08-01
00699753532618Cardiovascular Procedure KitTerumo Cardiovascular Systems CorporationCX-BE135X2024-08-08
00699753532632Cardiovascular Procedure KitTerumo Cardiovascular Systems CorporationCX-FR4152024-08-09
00699753532649Cardiovascular Procedure KitTerumo Cardiovascular Systems CorporationCX-FR4162024-08-09
00699753532656Cardiovascular Procedure KitTerumo Cardiovascular Systems Corporation783582024-08-16
00699753532717Cardiovascular Procedure KitTerumo Cardiovascular Systems Corporation670182024-08-23
00699753532762Cardiovascular Procedure KitTerumo Cardiovascular Systems Corporation670202024-08-26
00699753532786Cardiovascular Procedure KitTerumo Cardiovascular Systems CorporationCX-FR4662024-08-26
00699753532793Cardiovascular Procedure KitTerumo Cardiovascular Systems Corporation783942024-08-28
00699753532809Cardiovascular Procedure KitTerumo Cardiovascular Systems CorporationCX-FR4702024-09-10
00699753532816Cardiovascular Procedure KitTerumo Cardiovascular Systems CorporationCX-FR4682024-09-10
00699753532830Cardiovascular Procedure KitTerumo Cardiovascular Systems Corporation783682024-09-11
00699753532847Cardiovascular Procedure KitTerumo Cardiovascular Systems CorporationCX-FR4672024-09-11
00699753532892Cardiovascular Procedure KitTerumo Cardiovascular Systems Corporation783852024-09-25
00699753532939Cardiovascular Procedure KitTerumo Cardiovascular Systems Corporation670212024-09-27
00699753532946Cardiovascular Procedure KitTerumo Cardiovascular Systems Corporation783642024-09-27
00699753532960Cardiovascular Procedure KitTerumo Cardiovascular Systems Corporation783262024-09-27
00699753532977Cardiovascular Procedure KitTerumo Cardiovascular Systems Corporation782972024-10-01
00699753532984Cardiovascular Procedure KitTerumo Cardiovascular Systems Corporation782992024-10-01
00699753532991Cardiovascular Procedure KitTerumo Cardiovascular Systems Corporation782982024-10-02
00699753533004Cardiovascular Procedure KitTerumo Cardiovascular Systems Corporation783252024-10-02
00699753533028Cardiovascular Procedure KitTerumo Cardiovascular Systems Corporation782942024-10-09
00812261012605ARMADAALLWIN MEDICAL DEVICES, INC.ARMADA Nottingham One Step Dilator 6F/10F2023-07-31
00812261012612ARMADAALLWIN MEDICAL DEVICES, INC.ARMADA Nottingham One Step Dilator 6F/12F2023-07-31
00812261012988Meatal Dilator AdultALLWIN MEDICAL DEVICES, INC.MDA2020-09-17
00812261012995Meatal Dilator Pediatric ALLWIN MEDICAL DEVICES, INC.MDP2020-09-17
00846338001353Access NeedleELLIQUENCE, LLCN6-D5/12026-05-06
00888867039797Arthrex®ARTHREX, INC.AR-65212018-08-03
00888867251304Arthrex®ARTHREX, INC.AR-45052018-08-03
03600040255728Porges ColoplastColoplast A/SRBA0082019-06-30
03600040255773Porges ColoplastColoplast A/SRBA0102019-06-30
03600040255827Porges ColoplastColoplast A/SRBA0122019-06-30
03600040255872Porges ColoplastColoplast A/SRBB0102019-06-30
03600040255940Porges ColoplastColoplast A/SRBB0142019-06-30
03600040256015Porges ColoplastColoplast A/SRBC0082019-06-30