Atlas FDA

MEDIPLUS SINGLE USE GI MANOMETRY CATHETER

FDA 510(k) clearance K013704 · decided 2002-08-05

Clearance details

K-number
K013704
Device name
MEDIPLUS SINGLE USE GI MANOMETRY CATHETER
Applicant
Mediplus , Ltd.
Decision
Substantially Equivalent
Date received
2001-11-08
Decision date
2002-08-05
Days to decision
270 days
Clearance type
Traditional
Product code
KLA
Device class
2
Regulation number
876.1725
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
St. Petersburg, FL, US
Third-party review
No
Expedited review
No

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MEDTRONIC SINGLE USE ESOPHAGEAL MANOMETRIC CATHETER, MEDTRONIC SINGLE USE ANORECTAL MANOMETRIC CATHETER (K032138)Medtronic Vascular2003-10-09
COMPASS ESOPHAGEAL PRESSURE CATHETER, MODEL GIE-8500, COMPASS ANO-RECTAL PRESSURE CATHETER, MODEL GIA-8500 (K022023)Clinical Innovations, Inc.2003-01-07
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Recalls involving this device

No recalls on record reference this clearance.