Atlas FDA

Kahook Dual Blade Glide (KDB Glide)

FDA 510(k) clearance K220891 · decided 2024-05-17

Clearance details

K-number
K220891
Device name
Kahook Dual Blade Glide (KDB Glide)
Applicant
New World Medical, Inc.
Decision
Substantially Equivalent
Date received
2022-03-28
Decision date
2024-05-17
Days to decision
781 days
Clearance type
Traditional
Product code
QUQ
Device class
2
Regulation number
878.4400
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Rancho Cucamonga, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.