OSTOMY APPLIANCE W/DEODORIZING FILTER— 510(k) K781373
Substantially EquivalentHollister, Inc.
FDA 510(k) clearance K781373 for OSTOMY APPLIANCE W/DEODORIZING FILTER, Substantially Equivalent on 1978-09-20. Applicant: Hollister, Inc.. Device class: 1.
Clearance details
- Applicant
- Hollister, Inc.
- Product code
- Code EXB
- Device class
- Class 1
- Regulation
- 21 CFR 876.5900
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code EXB
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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 EXB
product code EXB- Injury
- 145
- Total
- 145
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.