FDA.reportPublic FDA data

EndoFLIP

Primary DI
05391530810029
Brand
EndoFLIP
Company
CROSPON LIMITED
Model
EF-322
Device description
EndoFLIP Measurement Catheter for use with EndoFLIP System
Published
2016-08-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FFXSystem, Gastrointestinal Motility (Electrical)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFXSystem, Gastrointestinal Motility (Electrical)Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120997000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120997000BAROSTAT SOFTWARE OPTIONCrospon, Ltd.2012-08-27FFX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391530810029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391530810029053915308100295391530810029

GMDN Terms#

Term, Definition table
TermDefinition
Oesophageal motility analysis systemAn assembly of devices designed to evaluate peristaltic motility in the oesophagus by measuring pressure on an intraluminal catheter/probe at several points (including LES); it also measures pH, respiration, and swallowing with appropriate sensors. In addition to a monitor display, computer, and software, it usually includes nonperfusion catheters to measure pressures directly and/or perfusion catheters and extracorporeal transducers to measure pressure indirectly. The system is intended to evaluate patients with dysphagia, gastro-oesophageal reflux disease (GERD), and/or noncardiac chest pain; it is also used to assess connective tissue and neuromuscular disease.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8552767766info@crospon.com

Regulatory Flags#

DUNS number
989779517
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391530810159EsoFLIP ES-3102020-04-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10678467508437Mui ScientificH & A Mui Enterprises IncFFX2026-04-15
10678467508413Mui ScientificH & A Mui Enterprises IncFFX2026-01-23
00678467508416Mui ScientificH & A Mui Enterprises IncFFX2026-01-23
00851607003501mcompass Anorectal Balloon Expulsion CatheterMEDSPIRA, LLCFFX2025-12-30
00678467508393Mui ScientificH & A Mui Enterprises IncFFX2025-11-04
00678467508386Mui ScientificH & A Mui Enterprises IncFFX2025-10-21
00678467508362Mui ScientificH & A Mui Enterprises IncFFX2025-09-15
10678467508352Mui ScientificH & A Mui Enterprises IncFFX2025-08-28
00678467508355Mui ScientificH & A Mui Enterprises IncFFX2025-08-28
10678467508345Mui ScientificH & A Mui Enterprises IncFFX2025-08-26
00678467508348Mui ScientificH & A Mui Enterprises IncFFX2025-08-26
10678467508338Mui ScientificH & A Mui Enterprises IncFFX2025-08-21
00678467508331Mui ScientificH & A Mui Enterprises IncFFX2025-08-21
10884521855441ManoScanGiven Imaging, Inc.FFX2025-08-21
10678467508307Mui ScientificH & A Mui Enterprises IncFFX2025-07-22
10678467508314Mui ScientificH & A Mui Enterprises IncFFX2025-07-22
00678467508300Mui ScientificH & A Mui Enterprises IncFFX2025-07-22
00678467508317Mui ScientificH & A Mui Enterprises IncFFX2025-07-22
10678467508109Mui ScientificH & A Mui Enterprises IncFFX2025-07-03
10678467508291Mui ScientificH & A Mui Enterprises IncFFX2025-07-03
00678467508102Mui ScientificH & A Mui Enterprises IncFFX2025-07-03
00678467508294Mui ScientificH & A Mui Enterprises IncFFX2025-07-03
00678467508270Mui ScientificH & A Mui Enterprises IncFFX2025-06-11
00678467508287Mui ScientificH & A Mui Enterprises IncFFX2025-06-11
00816734023433Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FFX2025-05-16
00816734023440Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FFX2025-05-16
00816734023457Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FFX2025-05-16
00816734023464Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FFX2025-05-16
00816734023471Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FFX2025-05-16
00816734023488Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FFX2025-05-16