HOUTS HYSTERECTOMY DRAIN— 510(k) K894220
Substantially EquivalentHelix Medical, Inc.
FDA 510(k) clearance K894220 for HOUTS HYSTERECTOMY DRAIN, Substantially Equivalent on 1989-08-24. Applicant: Helix Medical, Inc.. Device class: 1.
Clearance details
- Applicant
- Helix Medical, Inc.
- Product code
- Code GBW
- 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
- Santa Barbera, CA, US
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Adverse events under product code GBW
product code GBW- Death
- 6
- Total
- 6
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.