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Trip Tonometry Catheter, 16F

by Datex-Engstrom, Inc. 510(k)

Active United States

510(k) K983366

Overview

The Trip Tonometer Catheter, 16F, is a non-invasive medical device designed for the measurement of intra-abdominal pressure. It features a unique design that allows for accurate and reliable readings, making it an essential tool for healthcare professionals. With its high accuracy and minimal discomfort to patients, this catheter is widely used in various clinical settings.

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK983366 Date23 Dec 1998ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
KNT
Device Class
Class II
Regulation
21 CFR Part 876.5980
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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