SILASTIC U-TUBE KIT— 510(k) K781526
Substantially EquivalentDow Corning Corp. Healthcare Industries Materials
FDA 510(k) clearance K781526 for SILASTIC U-TUBE KIT, Substantially Equivalent on 1978-09-20. Applicant: Dow Corning Corp. Healthcare Industries Materials. Device class: 1.
Clearance details
- Applicant
- Dow Corning Corp. Healthcare Industries Materials
- Product code
- Code GBO
- 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
- Mchenry, IL, US
Recent devices under product code GBO
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- K854905 — PERCUTANEOUS NEPHROSTOMY SETS (LOOP TECHNIQUE)
- K854906 — PERCUTANEOUS NEPHROSTOMY SETS (OTTO)
More clearances from Dow Corning Corp. Healthcare Industries Materials
view allAdverse events under product code GBO
product code GBO- Death
- 8
- Injury
- 236
- Total
- 244
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.