HOLLISTER WOUND CARE BARRIER— 510(k) K862572
Substantially Equivalent for Some IndicationsHollister, Inc.
FDA 510(k) clearance K862572 for HOLLISTER WOUND CARE BARRIER, Substantially Equivalent for Some Indications on 1986-08-04. Applicant: Hollister, Inc.. Device class: Unclassified.
Clearance details
- Applicant
- Hollister, Inc.
- Product code
- Code FRO
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Libertyville, IL, US
Recent devices under product code FRO
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- K100273 — INSTAFLO BOWEL CATHETER SYSTEM KIT
- K090960 — VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184,
- K083153 — ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007
- K050483 — EVADRI BLADDER CONTROL SYSTEMS
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.