Catalog Number

-

Brand Name

EndoFLIP

Version/Model Number

LK-200

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K183072

Product Code

FFX

Product Code Name

SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)

Public Device Record Key

ca666c2a-0588-464b-bc11-f4cd94b11c80

Public Version Date

March 23, 2021

Public Version Number

1

DI Record Publish Date

March 15, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-