HOLLISTER HORIZONTAL DRAIN/TUBE ATTACHMENT DEVICE— 510(k) K922739
Substantially EquivalentHollister, Inc.
FDA 510(k) clearance K922739 for HOLLISTER HORIZONTAL DRAIN/TUBE ATTACHMENT DEVICE, Substantially Equivalent on 1992-08-06. Applicant: Hollister, Inc.. Device class: 1.
Clearance details
- Applicant
- Hollister, Inc.
- Product code
- Code GBX
- Device class
- Class 1
- Regulation
- 21 CFR 878.4200
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Libertyville, IL, US
Recent devices under product code GBX
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- K083153 — ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007
- K050483 — EVADRI BLADDER CONTROL SYSTEMS
Adverse events under product code GBX
product code GBX- Death
- 16
- Injury
- 583
- Malfunction
- 3,578
- Other
- 1
- Total
- 4,178
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.