Atlas FDA

Seal Single Use Biopsy Valve

FDA 510(k) clearance K182275 · decided 2018-09-13

Clearance details

K-number
K182275
Device name
Seal Single Use Biopsy Valve
Applicant
Boston Scientific Corporation
Decision
Substantially Equivalent
Date received
2018-08-22
Decision date
2018-09-13
Days to decision
22 days
Clearance type
Special
Product code
OCX
Device class
2
Regulation number
876.1500
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
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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