STORZ MICROFLOW PHACOEMULSIFICATION NEEDLE— 510(k) K954340
Substantially EquivalentStorz
FDA 510(k) clearance K954340 for STORZ MICROFLOW PHACOEMULSIFICATION NEEDLE, Substantially Equivalent on 1995-12-14. Applicant: Storz. Device class: 2.
Clearance details
- Applicant
- Storz
- Product code
- Product 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
Recent devices under product code HQC
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view all- K960007 — STORZ MVS 1011A DISPOSABLE FIBEROPTIC ENDOILLUMINATOR
- K952151 — STORZ OPHTHALMIC BIPOLAR CAUTERY INSTRUMENTS (D8200, D8201, D8203) AND BIPOLAR CORDS (D8202, D8204)
- K930278 — STORZ COMPUSCAN AB
- K926512 — STORZ MODIFIED PHACO NEEDLE WITH INSULATION SLEEVE
- K913504 — STORZ MICRO CUTTER 25 GAUGE PACK
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.