FDA.reportPublic FDA data

EndoClot Applicator

Primary DI
16972011720110
Brand
EndoClot Applicator
Company
EndoClot Plus Co.,Ltd.
Model
EA230
Published
2021-06-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162197000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162197000EndoClotEndoclot Plus Co., Ltd.2017-01-18GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
46972011720111PackageGS15In Commercial Distribution
16972011720110PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4697201172011146972011720111
1697201172011016972011720110

GMDN Terms#

Term, Definition table
TermDefinition
Haematological concentrate/haemostatic agent applicator cannula, endoscopic, single-useA long flexible or rigid tube with an atraumatic tip intended to be used during an endoscopic/laparoscopic procedure to provide access for the administration of a haematological concentrate and/or haemostatic agent (e.g., thrombin, platelet concentrate, polysaccharide) to a bleeding surgical site, typically to facilitate haemostasis and healing, in conjunction with an applicator such as a syringe [not included]. It is designed to be inserted into the body percutaneously, via a port or endoscope/laparoscope. It may have a single or dual-channel(s) for administration of one or two agent(s); a channel for connection to a gas pump for spraying may be incorporated. This is a single-use device.

Regulatory Flags#

DUNS number
544357082
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16972011720219EndoClot SIS-30SIS-302021-02-10
16972011720226EndoClot SIS-152021-06-23
16972011720240EndoClot SISSIS-30-01SIS-30-012021-11-16
16972011720257EndoClot SISSIS-15-01SIS-15-012021-11-16
16972011720516EndoClotEPAC-1T2022-03-18
26972011720513EndoClotEPAC-1T2022-03-18
16972011720011EndoClotEPK2302-012022-03-15
26972011720018EndoClotEPK2302-012022-03-15
16972011720318EndoClot Air CompressorEPAC-22021-06-23
26972011720247EndoClot SISSIS-30-01SIS-30-012021-11-16
26972011720254EndoClot SISSIS-15-01SIS-15-012021-11-16
16972011720028EndoClot PHSEPK2303EPK2303-012021-06-23
16972011720035EndoClot PHSEPK2305EPK2305-012021-06-23
26972011720025EndoClot PHSEPK23032021-06-23
26972011720032EndoClot PHSEPK23052021-06-23
46972011720111EndoClot ApplicatorEA2302021-06-23
26972011720223EndoClot SIS-152021-06-23
26972011720315EndoClot Air CompressorEPAC-22021-06-23
26972011720216EndoClot SIS-30SIS-302021-02-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776435295MillenniumAvalign Technologies, Inc.GCJ2026-10-19
00190776435455MillenniumAvalign Technologies, Inc.GCJ2026-10-19
B354OSCVORTH80Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH81Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH82Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH83Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH84Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH85Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH89Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
04548736175013OLYMPUSSONY CORPORATIONGCJ2026-10-15
04548736175068OLYMPUSSONY CORPORATIONGCJ2026-10-15
04548736175112OLYMPUSSONY CORPORATIONGCJ2026-10-15
00190776434922MillenniumAvalign Technologies, Inc.GCJ2026-10-14
00190776434823MillenniumAvalign Technologies, Inc.GCJ2026-10-13
00190776434854MillenniumAvalign Technologies, Inc.GCJ2026-10-13
B382SD56300680Surgical DirectSurgical Direct, Inc.GCJ2026-10-13
B382SD563006820Surgical DirectSurgical Direct, Inc.GCJ2026-10-13
00190776434250MillenniumAvalign Technologies, Inc.GCJ2026-10-09
00848657078481AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GCJ2026-10-08
00848657078498AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GCJ2026-10-08
00190776433697MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433703MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433710MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433727MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433338MillenniumAvalign Technologies, Inc.GCJ2026-10-05
00190776433345MillenniumAvalign Technologies, Inc.GCJ2026-10-05
00190776433031MillenniumAvalign Technologies, Inc.GCJ2026-10-01
00190776433079MillenniumAvalign Technologies, Inc.GCJ2026-10-01
00190776432911MillenniumAvalign Technologies, Inc.GCJ2026-09-30
00190776432928MillenniumAvalign Technologies, Inc.GCJ2026-09-30