MEDLINE TITANIUM HEMOCLIPS— 510(k) K962016
Substantially EquivalentMedline Industries, Inc.
FDA 510(k) clearance K962016 for MEDLINE TITANIUM HEMOCLIPS, Substantially Equivalent on 1996-07-24. Applicant: Medline Industries, Inc.. Device class: 2.
Clearance details
- Applicant
- Medline Industries, Inc.
- Product code
- Code FZP
- Device class
- Class 2
- Regulation
- 21 CFR 878.4300
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mundelein, IL, US
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Adverse events under product code FZP
product code FZP- Death
- 11
- Injury
- 726
- Malfunction
- 10,830
- Other
- 1
- Total
- 11,568
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.