HOLLISTER VERTICAL DRAIN/TUBE ATTACHMENT DEVICE— 510(k) K932855
Substantially EquivalentHollister, Inc.
FDA 510(k) clearance K932855 for HOLLISTER VERTICAL DRAIN/TUBE ATTACHMENT DEVICE, Substantially Equivalent on 1993-10-13. Applicant: Hollister, Inc.. Device class: 2.
Clearance details
- Applicant
- Hollister, Inc.
- Product code
- Code KNT
- Device class
- Class 2
- Regulation
- 21 CFR 876.5980
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Libertyville, IL, US
Recent devices under product code KNT
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 KNT
product code KNT- Death
- 192
- Injury
- 6,034
- Malfunction
- 4,049
- Other
- 1
- Total
- 10,276
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 K932855
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 K932855.
Data sourced from openFDA. This site is unofficial and independent of the FDA.