DERMABOND PRINEO SKIN CLOSURE SYSTEM— 510(k) K133864
Substantially EquivalentETHICON, Inc.
FDA 510(k) clearance K133864 for DERMABOND PRINEO SKIN CLOSURE SYSTEM, Substantially Equivalent on 2014-03-10. Applicant: ETHICON, Inc.. Device class: 2.
Clearance details
- Applicant
- ETHICON, Inc.
- Product code
- Code OMD
- Device class
- Class 2
- Regulation
- 21 CFR 878.4011
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Somerville, NJ, US
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Adverse events under product code OMD
product code OMD- Injury
- 1,134
- Total
- 1,134
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 →
Recalls naming K133864
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K133864.
Data sourced from openFDA. This site is unofficial and independent of the FDA.