INCARE ADVANCE; INTERMITTENT CATHETER, PLUS INTERMITTENT CATHETER, PLUS KIT— 510(k) K013483
Substantially EquivalentHollister, Inc.
FDA 510(k) clearance K013483 for INCARE ADVANCE; INTERMITTENT CATHETER, PLUS INTERMITTENT CATHETER, PLUS KIT, Substantially Equivalent on 2002-01-14. Applicant: Hollister, Inc.. Device class: 2.
Clearance details
- Applicant
- Hollister, Inc.
- Product code
- Code KOD
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Libertyville, IL, US
Recent devices under product code KOD
view allMore clearances from Hollister, Inc.
view all- K123804 — INSTAFLO BOWEL CATHETER SYSTEM KIT
- 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 KOD
product code KOD- Death
- 5
- Injury
- 1,129
- Malfunction
- 7,019
- Total
- 8,153
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.