Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter— 510(k) K183461
UnknownTeleflexmedical, Inc.
FDA 510(k) clearance K183461 for Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter, Unknown on 2019-05-08. Applicant: Teleflexmedical, Inc.. Device class: 2.
Clearance details
- Applicant
- Teleflexmedical, Inc.
- Product code
- Code GBM
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Traditional
- Location
- Morrisville, NC, US
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More clearances from Teleflexmedical, Inc.
view allAdverse events under product code GBM
product code GBM- Injury
- 397
- Malfunction
- 1,404
- Total
- 1,801
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.