SKINCOTE— 510(k) K882567
Substantially Equivalent for Some IndicationsDynarex Corp.
FDA 510(k) clearance K882567 for SKINCOTE, Substantially Equivalent for Some Indications on 1988-10-05. Applicant: Dynarex Corp.. Device class: Unclassified.
Clearance details
- Applicant
- Dynarex Corp.
- Product code
- Code FRO
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Brewster, NY, US
Recent devices under product code FRO
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view all- K052743 — DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921
- K052314 — DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGE
- K012816 — DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414
- K012957 — TOWEL DRAPE, MODELS 4409, 4410
- K012917 — DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B
Adverse events under product code FRO
product code FRO- Death
- 30
- Injury
- 653
- Malfunction
- 479
- Other
- 11
- Total
- 1,173
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.