Needle, Phacoemulsification, Reprocessed
Needle, Phacoemulsification, Reprocessed is a medical device type in the Ophthalmic specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.
US Regulatory Classifications
Device Characteristics
No
No
No
Eligible
Definition
Needle for phacoemulsification device to remove cataractous lens. Same as needle for main phacoemulsification device and un-reprocessed needle with product code HQC, except this is a "reprocessed" needle. The Phacoemulsification device is NOT reprocessed, just the needle. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
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