RUSCH BRONCHUS BLOCKER KIT— 510(k) K010596

Name: FDA 510(k) clearance K010596
Creator: U.S. Food and Drug Administration
Published: 2001-11-21

Substantially Equivalent

Rusch Intl.

FDA 510(k) clearance K010596 for RUSCH BRONCHUS BLOCKER KIT, Substantially Equivalent on 2001-11-21. Applicant: Rusch Intl.. Device class: 2.

Clearance details

Applicant: Rusch Intl.
Product code: Code CBI
Device class: Class 2
Regulation: 21 CFR 868.5740
Advisory panel: Anesthesiology
Date received: 2001-02-28
Decision date: 2001-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jaffrey, NH, US

Download summary PDF View on FDA.gov ↗

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K033023 — INTERMITTENT URETHRAL CATHETERS2003-12-23
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K023666 — RUSCH GUIDED CHOLANGIOGRAPHY CATHETER2003-06-17
K023918 — RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS2003-03-28
K023964 — RUSCH MICROLARYNGEAL TUBE2002-12-23

Adverse events under product code CBI

product code CBI

Death: 4
Malfunction: 594
Total: 598

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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