STORZ PHACOEMULSIFICATION NEEDLES— 510(k) K946176
Substantially EquivalentStorz Instrument Co.
FDA 510(k) clearance K946176 for STORZ PHACOEMULSIFICATION NEEDLES, Substantially Equivalent on 1995-02-14. Applicant: Storz Instrument Co.. Device class: 2.
Clearance details
- Applicant
- Storz Instrument Co.
- Product code
- Code HQC
- Device class
- Class 2
- Regulation
- 21 CFR 886.4670
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Louis, MO, US
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- 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 HQC
product code HQC- Injury
- 2,378
- Malfunction
- 8,768
- Total
- 11,146
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.