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Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm)

FDA 510(k) clearance K162449 · decided 2017-05-05

Clearance details

K-number
K162449
Device name
Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm)
Applicant
AngioDynamics, Inc.
Decision
Substantially Equivalent
Date received
2016-09-01
Decision date
2017-05-05
Days to decision
246 days
Clearance type
Traditional
Product code
NEY
Device class
2
Regulation number
878.4400
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Marlborough, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.