FDA.reportPublic FDA data

Sidecar External Working Channel

Primary DI
00854924006118
Brand
Sidecar External Working Channel
Company
C2 THERAPEUTICS, INC.
Model
FG-1011
Catalog number
FG-1011
Device description
Sidecar External Working Channel, Endoscopic Accessory
Published
2016-10-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
FEDEndoscopic Access Overtube, Gastroenterology-Urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FEDEndoscopic Access Overtube, Gastroenterology-UrologyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150083000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150083000Sidecar External Working ChannelC2 Therapeutics2015-04-14FED

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854924006118PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854924006118008549240061188549240061180854924006118

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope assembly adaptorA connecting component of a flexible or rigid endoscope assembly intended to be used to join one or more endoscope elements to create a complete endoscope assembly, or to enable the connection of other devices (e.g., a laser). It may also be fitted with stop-cocks or instrument ports for the introduction of devices (e.g., catheters), fluids, gases, or to perform aspiration. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
929139249
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854924006064Controller, Full/SwipeFG-1006FG-10062016-10-19
00854924006088Catheter, Full, StandardFG-1008FG-10082016-10-19
00854924006095C2 CryoBalloon Focal Catheter, StandardFG-1009FG-10092016-10-19
00854924006125C2 CryoBalloon Focal ControllerFG-1012FG-10122016-10-19
00854924006156C2 CryoBalloon Swipe Catheter, StandardFG-1015FG-10152016-10-19
00854924006248C2 CryoBalloonFG-1024FG-10242018-03-26
00854924006262C2 CryoBalloonFG-1026FG-10262018-03-26
00854924006279C2 CryoBalloonFG-1027FG-10272018-03-26
00854924006286C2 CryoBalloonFG-1028FG-10282018-03-08
00854924006309C2 CryoBalloonFG-1030FG-10302018-03-08
00854924006316C2 CryoBalloonFG-1031FG-10312018-03-08
00854924006323C2 CryoBalloon Full 8 CatheterFG-1032FG-10322016-10-19
00854924006330C2 CryoBalloon Focal Pear Catheter FG-1033FG-10332016-10-19
00854924006101C2 CryoBalloon Cartridge, RegularFG-1010FG-10102016-10-19
00854924006132C2 CryoBalloon Cartridge, LargeFG-1013FG-10132016-10-19
00854924006170C2 CryoBalloonFG-1017FG-10172018-03-08
00854924006163BOA Endoscopic ValveFG-1016FG-10162016-10-19
00854924006187C2 CryoBalloonFG-1018FG-10182018-03-08

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