THE DEXTRA PRECISION POWER UNIT— 510(k) K853778
Substantially EquivalentStorz Instrument Co.
FDA 510(k) clearance K853778 for THE DEXTRA PRECISION POWER UNIT, Substantially Equivalent on 1985-11-13. Applicant: Storz Instrument Co.. Device class: 1.
Clearance details
- Applicant
- Storz Instrument Co.
- Product code
- Code GEY
- Device class
- Class 1
- Regulation
- 21 CFR 878.4820
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Louis, MO, US
Recent devices under product code GEY
view allMore clearances from Storz Instrument Co.
view all- K980100 — STORZ DP4210 VENTURI ECONOMY ANTERIOR PACK AND DP5000 ASC DAYPACK
- K980488 — STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEM
- K972664 — STORZ MILLENNIUM VISCOUS FLUID SYSTEM
- K971439 — STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLES
- K964743 — STORZ E8010 ERGOTEC/PREMIERE ADAPTOR
Adverse events under product code GEY
product code GEY- Malfunction
- 7,488
- Total
- 7,488
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.