Atlas FDA

CoreDx™ Pulmonary Mini-Forceps

FDA 510(k) clearance K183085 · decided 2019-03-08

Clearance details

K-number
K183085
Device name
CoreDx™ Pulmonary Mini-Forceps
Applicant
Boston Scientific Corporation
Decision
Substantially Equivalent
Date received
2018-11-06
Decision date
2019-03-08
Days to decision
122 days
Clearance type
Traditional
Product code
EOQ
Device class
2
Regulation number
874.4680
Medical specialty
Ear, Nose, Throat
Advisory committee
Ear, Nose, Throat
Location
Marlboro, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

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