DeviceClearance

RUSCH ULTRA TRACHEOFLEX FENESTRATED KIT CUFFED,UNCUFFED/ RUSCH TRACHEOFLEX TRACHEOSTOMY KIT UNCUFFED STERILE— 510(k) K964056

Substantially Equivalent

Rusch Intl.

FDA 510(k) clearance K964056 for RUSCH ULTRA TRACHEOFLEX FENESTRATED KIT CUFFED,UNCUFFED/ RUSCH TRACHEOFLEX TRACHEOSTOMY KIT UNCUFFED STERILE, Substantially Equivalent on 1997-10-10. Applicant: Rusch Intl.. Device class: 2.

Clearance details

Applicant
Rusch Intl.
Product code
Code JOH
Device class
Class 2
Regulation
21 CFR 868.5800
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Jeffrey, NH, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code JOH

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More clearances from Rusch Intl.

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Adverse events under product code JOH

product code JOH
Death
42
Injury
1,344
Malfunction
5,608
Other
1
Total
6,995

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

Recalls naming K964056

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K964056.

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