ENK FIBEROPTIC ATOMIZER SET— 510(k) K031966
UnknownCook, Inc.
FDA 510(k) clearance K031966 for ENK FIBEROPTIC ATOMIZER SET, Unknown on 2003-10-16. Applicant: Cook, Inc.. Device class: 2.
Clearance details
- Applicant
- Cook, Inc.
- Product code
- Code EOQ
- Device class
- Class 2
- Regulation
- 21 CFR 874.4680
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Traditional
- Location
- Bloomington, IN, US
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- K133597 — CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY
- K131772 — CANTATA(R) 2.9 MICROCATHETER
Adverse events under product code EOQ
product code EOQ- Death
- 135
- Injury
- 2,863
- Malfunction
- 21,662
- Total
- 24,660
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.