STORZ FIBEROPTIC REVERSE CUTTING KNIFE— 510(k) K933984
Substantially EquivalentStorz Instrument Co.
FDA 510(k) clearance K933984 for STORZ FIBEROPTIC REVERSE CUTTING KNIFE, Substantially Equivalent on 1994-01-25. Applicant: Storz Instrument Co.. Device class: 2.
Clearance details
- Applicant
- Storz Instrument Co.
- Product code
- Code HQE
- Device class
- Class 2
- Regulation
- 21 CFR 886.4150
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Louis, MO, US
Recent devices under product code HQE
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 HQE
product code HQE- Injury
- 156
- Malfunction
- 565
- Total
- 721
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.