PERCUTANEOUS NEPHROSTOMY SET— 510(k) K820867
Substantially EquivalentVan-Tec, Inc.
FDA 510(k) clearance K820867 for PERCUTANEOUS NEPHROSTOMY SET, Substantially Equivalent on 1982-04-13. Applicant: Van-Tec, Inc.. Device class: 1.
Clearance details
- Applicant
- Van-Tec, Inc.
- 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
- Walker, MI, US
Recent devices under product code GBO
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- K912109 — URESIL GENERAL PURPOSE DRAINAGE CATHETER
- K854905 — PERCUTANEOUS NEPHROSTOMY SETS (LOOP TECHNIQUE)
- K854906 — PERCUTANEOUS NEPHROSTOMY SETS (OTTO)
More clearances from Van-Tec, Inc.
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.