LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER— 510(k) K043241
Substantially EquivalentAstra Tech, Inc.
FDA 510(k) clearance K043241 for LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER, Substantially Equivalent on 2004-12-23. Applicant: Astra Tech, Inc.. Device class: 2.
Clearance details
- Applicant
- Astra Tech, Inc.
- Product code
- Code GBM
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Northborough, MA, US
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Adverse 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.