SilverCoat Silicone Foley Catheter— 510(k) K150550
Substantially EquivalentCovalontechnologies, Inc.
FDA 510(k) clearance K150550 for SilverCoat Silicone Foley Catheter, Substantially Equivalent on 2015-11-24. Applicant: Covalontechnologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Covalontechnologies, Inc.
- 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
- Mississauga, CA
Recent devices under product code EZL
view allMore clearances from Covalontechnologies, Inc.
view all- K163556 — MediClear PreOp
- K121819 — SURGICLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER
- K112549 — IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER
- K043296 — COLACTIVE AG COLLAGEN WITH SILVER ANTIMICROBIAL DRESSING
- K050177 — COLACTIVE COLLAGEN WOUND DRESSING
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.