Atlas FDA

FLEXIFLO OVER-THE-GUIDEWIRE GASTROSTOMY KIT

FDA 510(k) clearance K915110 · decided 1992-04-14

Clearance details

K-number
K915110
Device name
FLEXIFLO OVER-THE-GUIDEWIRE GASTROSTOMY KIT
Applicant
Abbott Laboratories
Decision
Unknown
Date received
1991-11-13
Decision date
1992-04-14
Days to decision
153 days
Clearance type
Traditional
Product code
KNT
Device class
2
Regulation number
876.5980
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Columbus, OH, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
20 French Ross Over-the-Guidewire Basic Gastrostomy KIt with Reinforced Webbed Bumper for recall (Z-0334-05)Abbott Laboratories2004-12-21
20 French Ross Flexiflo Over-the-Guidewire Complete Gastrostomy KIt with Reinforced Webbed recall (Z-0335-05)Abbott Laboratories2004-12-21

PMA approvals by this applicant

RecordFirmDate
ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046)Abbott Laboratories2025-04-03
ARCHITECT AFP / Alinity i AFP (P120008/S030)Abbott Laboratories2025-04-03
ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043)Abbott Laboratories2025-04-03
ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066)Abbott Laboratories2025-04-03
ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012)Abbott Laboratories2024-09-30