Submission Details
| 510(k) Number | K023918 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 25, 2002 |
| Decision Date | March 28, 2003 |
| Days to Decision | 123 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
Cleared
Traditional
K023918 - RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS
(FDA 510(k) Clearance)
Mar 2003
Decision
123d
Days
Class 2
Risk
K023918 is an FDA 510(k) clearance for the RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS, a Tube Tracheostomy And Tube Cuff (Class II — Special Controls, product code JOH), submitted by Rusch Intl. (Jaffrey, US). The FDA issued a Cleared decision on March 28, 2003, 123 days after receiving the submission on November 25, 2002. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5800.
Device Classification
| Product Code | JOH — Tube Tracheostomy And Tube Cuff |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.5800 |
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