Atlas FDA

GYRUS ACMI PK BUTTON ELECTRODE

FDA 510(k) clearance K093181 · decided 2010-02-24

Clearance details

K-number
K093181
Device name
GYRUS ACMI PK BUTTON ELECTRODE
Applicant
Gyrus Acmi, Inc.
Decision
Substantially Equivalent
Date received
2009-10-08
Decision date
2010-02-24
Days to decision
139 days
Clearance type
Traditional
Product code
FAS
Device class
2
Regulation number
876.4300
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Southborough, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Spiration® Valve System (P180007/S013)Gyrus Acmi, Inc.2024-08-16
Spiration Valve System Deployment Catheter and Loader (P180007/S012)Gyrus Acmi, Inc.2024-06-27
Spiration Valve System (P180007/S011)Gyrus Acmi, Inc.2023-09-22
SVS Deployment Catheter and Loader (P180007/S009)Gyrus Acmi, Inc.2022-05-12
Spiration Valve System (P180007/S008)Gyrus Acmi, Inc.2021-09-01
Falope Ring Band and Applicator Systems (P870076/S027)Gyrus Acmi, Inc.2021-05-19
Falope-Ring® Band and Applicator Systems (P870076/S026)Gyrus Acmi, Inc.2021-05-11
Spiration® Valve System (SVS) (P180007/S007)Gyrus Acmi, Inc.2020-12-23