Atlas FDA

Phacoemulsification Needle (Tip) and Irrigation Sleeve

FDA 510(k) clearance K192418 · decided 2020-05-27

Clearance details

K-number
K192418
Device name
Phacoemulsification Needle (Tip) and Irrigation Sleeve
Applicant
Raico, LLC
Decision
Substantially Equivalent
Date received
2019-09-04
Decision date
2020-05-27
Days to decision
266 days
Clearance type
Traditional
Product code
HQC
Device class
2
Regulation number
886.4670
Medical specialty
Ophthalmic
Advisory committee
Ophthalmic
Location
Westmont, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.