Monitor, Esophageal Motility, Anorectal Motility, And Tube

FDA product code KLA · 30 cleared devices

Class 2 Gastroenterology, Urology

Regulation: 21 CFR 876.1725
Review panel: GU
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-05-20 – 2025-02-12

KLA 2025-02-12

Fecobionics Anorectal System

Applicant Gi Bionics, LLC

K number K242666

View details →

KLA 2024-12-06

RED

Applicant Neuraxis, Inc.

K number K242304

View details →

KLA 2024-04-23

Solar™ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)

Applicant Laborie Medical Technologies, Corp.

K number K234107

View details →

KLA 2018-03-08

THD Anopress with THD SensyProbe

Applicant Thd Spa

K number K180135

View details →

KLA 2017-03-14

THD ANOPRESS

Applicant Thd Spa

K number K161785

View details →

KLA 2012-03-29

MCOMPASS ANORECTAL MANOMETRY SYSTEM

Applicant Medspira, LLC

K number K120088

View details →

KLA 2007-04-13

SINGLE USE ESOPHAGEAL MANOMETEY CATHETERS AND SINGLE USE ANO-RECTAL MANOMETRY CATHETERS

Applicant Sarmed Srl

K number K062362

View details →

KLA 2004-01-16

MEDIPLUS SINGLE USE LOWER GI MANOMETRY CATHETER

Applicant Mediplus , Ltd.

K number K031617

View details →

KLA 2003-10-09

MEDTRONIC SINGLE USE ESOPHAGEAL MANOMETRIC CATHETER, MEDTRONIC SINGLE USE ANORECTAL MANOMETRIC CATHETER

Applicant Medtronic Vascular

K number K032138

View details →

KLA 2003-01-07

COMPASS ESOPHAGEAL PRESSURE CATHETER, MODEL GIE-8500, COMPASS ANO-RECTAL PRESSURE CATHETER, MODEL GIA-8500

Applicant Clinical Innovations, Inc.

K number K022023

View details →

KLA 2002-08-05

MEDIPLUS SINGLE USE GI MANOMETRY CATHETER

Applicant Mediplus , Ltd.

K number K013704

View details →

KLA 1999-05-17

MANOMETRIC ASSEMBLIES

Applicant Dentsleeve Pty., Ltd.

K number K983665

View details →

KLA 1997-08-06

FLEXILOG LS

Applicant Oakfield Instruments, Ltd.

K number K964804

View details →

KLA 1997-03-04

FLEXILOG 3000

Applicant Oakfield Instruments, Ltd.

K number K964589

View details →

KLA 1996-11-04

FLEXILOG LS 13921

Applicant Oakfield Instruments, Ltd.

K number K961895

View details →

KLA 1996-06-11

ESOPHAGEAL MANOMETRY ANALYSIS MODULE

Applicant Synectics Medical, Inc.

K number K961070

View details →

KLA 1996-06-06

BIOVIEW MODEL S960000

Applicant Sandhill Scientific, Inc.

K number K961056

View details →

KLA 1996-06-04

7100 SWALLOWING WORKSTATION

Applicant Kay Elemetrics Corp.

K number K954798

View details →

KLA 1995-09-08

ANALGRAPH

Applicant Sandhill Scientific, Inc.

K number K941801

View details →

KLA 1994-08-23

CLA-COMPUTERIZED LARYNGEAL ANALYZER

Applicant H.I.L. Research, Ltd.

K number K922553

View details →

KLA 1993-12-13

MONOCRYSTANT PH/LES CATHETER, MODIFICATION

Applicant Synectics-Dantec

K number K914793

View details →

KLA 1991-01-25

PROVOCATIVE SENSITIVITY BALLOON

Applicant Wilson-Cook Medical, Inc.

K number K901125

View details →

KLA 1990-07-16

WILSON-COOK ESOPHAGEAL MOTILITY CATHETER

Applicant Wilson-Cook Medical, Inc.

K number K900239

View details →

KLA 1989-02-28

ZINETICS(R) EMC

Applicant Zinetics Medical, Inc.

K number K884527

View details →

KLA 1988-10-12

AMBULATORY PH DATA RECORDER SYSTEM, APH-2000

Applicant Intl. Biomedics, Inc.

K number K882551

View details →

KLA 1988-03-18

PC POLYGRAF

Applicant Synectics-Dantec

K number K872712

View details →

KLA 1982-06-22

SANDHILL DMS

Applicant Sandhill

K number K821588

View details →

KLA 1977-11-22

HILL TUBE

Applicant Physio-Control Corp.

K number K771723

View details →

KLA 1977-11-22

PRESSURE MONITOR MANOMETRIC SYS.

Applicant Physio-Control Corp.

K number K771265

View details →

KLA 1977-05-20

MONITOR, RESPIRATORY, TWO-GAS, RDC

Applicant Research Development Corp.

K number K770785

View details →