ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865— 510(k) K021142
Substantially EquivalentFortune Medical Instrument Corp.
FDA 510(k) clearance K021142 for ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865, Substantially Equivalent on 2002-10-01. Applicant: Fortune Medical Instrument Corp.. Device class: 2.
Clearance details
- Applicant
- Fortune Medical Instrument Corp.
- Product code
- Code EZL
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Taipei Hsien, TW
Recent devices under product code EZL
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view all- K022112 — FORTUNE ALL SILICONE STOMACH (GASTRIC) TUBES, MODEL 2020
- K021193 — FORTUNE SILICONE VACUUM SUCTION, MODEL #1300
- K014002 — ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890
- K980917 — ALL SLICONE DRAINAGE, PENROSE DRAIN, CWV DRAIN, THORACIC DRAIN TUBES AND CWV RESERVOIR
- K980919 — ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER
Adverse events under product code EZL
product code EZL- Death
- 6
- Injury
- 796
- Malfunction
- 4,989
- Other
- 1
- Total
- 5,792
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.