THE STORZ BIPOLAR PENCIL AND CORD— 510(k) K880293
Substantially EquivalentStorz Instrument Co.
FDA 510(k) clearance K880293 for THE STORZ BIPOLAR PENCIL AND CORD, Substantially Equivalent on 1988-03-17. Applicant: Storz Instrument Co.. Device class: 2.
Clearance details
- Applicant
- Storz Instrument Co.
- Product code
- Code GXI
- Device class
- Class 2
- Regulation
- 21 CFR 882.4725
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Louis, MO, US
Recent devices under product code GXI
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- K964743 — STORZ E8010 ERGOTEC/PREMIERE ADAPTOR
Adverse events under product code GXI
product code GXI- Death
- 3
- Injury
- 171
- Total
- 174
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.