FDA.reportPublic FDA data

Pathfinder® CR System

Primary DI
00850006222322
Brand
Pathfinder® CR System
Company
NEPTUNE MEDICAL INC.
Model
GI 014CR-1
Device description
The Pathfinder® CR System is a disposable endoscopy fluid management system for the 14mm ID Pathfinder®Endoscope Overtube. It is designed to evacuate retained blood, free-floating blood clots, and fluid from the stomach in adult patients (22 years of age or older). It also provides access for endoscopic device passage and exchange. The suction adapter is attached to the Overtube and connected to a foot pedal to control suction on/off functionality. The foot pedal is connected to a suction source with vacuum regulator that provides a range between 200 to 375 mmHg (26.7 to 50.0 kPa). It is for use only by medically licensed and trained gastroenterologists located in hospitals, clinics, and doctor offices.
Published
2024-07-09
Public version status
Update
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
FDSGastroscope And Accessories, Flexible/Rigid
FEDEndoscopic Access Overtube, Gastroenterology-Urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDSGastroscope And Accessories, Flexible/RigidGastroenterology, Urology2
FEDEndoscopic Access Overtube, Gastroenterology-UrologyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240853000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240853000Pathfinder® CR SystemNeptune Medical, Inc.2024-06-27FED

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850006222322PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850006222322008500062223228500062223220850006222322

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic suction valve, single-useA device intended to be fitted to an endoscope suction channel to enable the operator to control suction whist preventing inflow of air. It is in the form of an attachable valve that controls (opens/closes) the suction channel. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
075588994
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850006222032Pathfinder® Endoscope CapGI EC-0412-1GI EC-0412-12021-06-02
00850006222025Pathfinder® Endoscope Overtube with BalloonGI 110140B-12023-11-20
00850006222124Pathfinder® Endoscope Overtube with BalloonGI 085140B-1GI 110140B-12023-11-20
00850006222049Pathfinder® Endoscope OvertubeGI 065110-2GI 065110-22021-08-31
00850006222056Pathfinder® Endoscope OvertubeGI 085110-2GI 085110-22021-08-31
00850006222063Pathfinder® Endoscope OvertubeGI 145110-2GI 145110-22021-08-31
00850006222070Pathfinder® Endoscope OvertubeGI 065140-2GI 065140-22021-06-07
00850006222087Pathfinder® Endoscope OvertubeGI 110140-2GI 110140-22021-06-07
00850006222094Pathfinder® Endoscope OvertubeGI 065160-2GI 065160-22021-06-07
00850006222100Pathfinder® Endoscope OvertubeGI 085160-2GI 085160-22021-06-07
00850006222117Pathfinder® Endoscope OvertubeGI 110160-2GI 110160-22021-06-07
00850006222018PathfinderGI 085140-2GI 085140-22021-01-28
00850006222001Pathfinder®GI 085140GI 0851402020-07-20

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08809882470428Controller BEndoRobotics Co., Ltd.FDS2026-10-16
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