RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER— 510(k) K962472

Name: FDA 510(k) clearance K962472
Creator: U.S. Food and Drug Administration
Published: 1996-08-27

Substantially Equivalent

Rusch Intl.

FDA 510(k) clearance K962472 for RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER, Substantially Equivalent on 1996-08-27. Applicant: Rusch Intl.. Device class: 2.

Clearance details

Applicant: Rusch Intl.
Product code: Code FAP
Device class: Class 2
Regulation: 21 CFR 876.1620
Advisory panel: Gastroenterology, Urology
Date received: 1996-06-25
Decision date: 1996-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jeffrey, NH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FAP

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K113771 — SIGNAL GEAR URETHRAL CATHETER ELECTRODE2012-12-13
K974775 — SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGE1998-02-19
K963330 — URODYNAMIC ANALYSIS MODULE1997-04-03
K931175 — SCHUSTER DISPOSABLE BALLOON PROBE1994-04-01
K931179 — UROLAB SPECTRUM1993-11-18

More clearances from Rusch Intl.

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K033023 — INTERMITTENT URETHRAL CATHETERS2003-12-23
K030559 — RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEM2003-06-30
K023666 — RUSCH GUIDED CHOLANGIOGRAPHY CATHETER2003-06-17
K023918 — RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS2003-03-28
K023964 — RUSCH MICROLARYNGEAL TUBE2002-12-23

Recalls naming K962472

K-number listed on FDA's recall record

Z-1368-2018 — Rectal Catheters; Product Code Equivalent Code 580114 580114 Product Usage: Rectal Balloon Catheter is inserted into the rectum to measure the abdominal pressure as bladder filled.Class II·Terminated·Teleflex Medical Europe Ltd·20180315

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K962472.

Data sourced from openFDA. This site is unofficial and independent of the FDA.