Atlas FDA

URETERAL DOUBLE PIGTAIL STENT

FDA 510(k) clearance K834401 · decided 1984-03-22

Clearance details

K-number
K834401
Device name
URETERAL DOUBLE PIGTAIL STENT
Applicant
Hobbs Medical, Inc.
Decision
Substantially Equivalent
Date received
1983-12-14
Decision date
1984-03-22
Days to decision
99 days
Clearance type
Traditional
Product code
FAD
Device class
2
Regulation number
876.4620
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6001 recall (Z-0037-2023)Hobbs Medical, Inc.2022-10-07
Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number:6004 recall (Z-0038-2023)Hobbs Medical, Inc.2022-10-07
Hobbs Biliary Pigtail Stent Kits (containing 6105) Catalog Number: 6023 recall (Z-0039-2023)Hobbs Medical, Inc.2022-10-07
Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6024 recall (Z-0040-2023)Hobbs Medical, Inc.2022-10-07
Hobbs Biliary Pigtail Stent Kits (contains 3412) Catalog Number: 6027 recall (Z-0041-2023)Hobbs Medical, Inc.2022-10-07
Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6028 recall (Z-0042-2023)Hobbs Medical, Inc.2022-10-07
Hobbs Biliary Pigtail Stent Kits Catalog Number: 6104 recall (Z-0043-2023)Hobbs Medical, Inc.2022-10-07
Hobbs Biliary Pigtail Stent Kits Catalog Number: 6105 recall (Z-0044-2023)Hobbs Medical, Inc.2022-10-07
Hobbs Biliary Pigtail Stent Kits Catalog Number: 6108 recall (Z-0045-2023)Hobbs Medical, Inc.2022-10-07