Atlas FDA

Guidewire Locking Device

FDA 510(k) clearance K220247 · decided 2022-03-29

Clearance details

K-number
K220247
Device name
Guidewire Locking Device
Applicant
Micro-Tech (Nanjing) Co., Ltd.
Decision
Substantially Equivalent
Date received
2022-01-28
Decision date
2022-03-29
Days to decision
60 days
Clearance type
Traditional
Product code
ODC
Device class
2
Regulation number
876.1500
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Nanjing, CN
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.