STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEM— 510(k) K980488
Substantially EquivalentStorz Instrument Co.
FDA 510(k) clearance K980488 for STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEM, Substantially Equivalent on 1998-03-23. 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
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- K971439 — STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLES
- K964743 — STORZ E8010 ERGOTEC/PREMIERE ADAPTOR
- K960024 — STORZ D7120 PHACO HANDPIECE MAINTENANCE KIT & STORZ D7125 PHACO HANDPIECE NEEDLE WRENCH
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.