Atlas FDA

Single Use Endoscope Valves Set

FDA 510(k) clearance K192048 · decided 2020-05-14

Clearance details

K-number
K192048
Device name
Single Use Endoscope Valves Set
Applicant
Anrei Medical (Hangzhou) Co., Ltd.
Decision
Substantially Equivalent
Date received
2019-07-31
Decision date
2020-05-14
Days to decision
288 days
Clearance type
Traditional
Product code
ODC
Device class
2
Regulation number
876.1500
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Hangzhou, CN
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.