Atlas FDA

MaxTack™ Motorized Fixation Device

FDA 510(k) clearance K231240 · decided 2023-09-08

Clearance details

K-number
K231240
Device name
MaxTack™ Motorized Fixation Device
Applicant
Covidien
Decision
Substantially Equivalent
Date received
2023-04-28
Decision date
2023-09-08
Days to decision
133 days
Clearance type
Traditional
Product code
OCW
Device class
2
Regulation number
876.1500
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
North Haven, CT, 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
MODEL 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S006)Covidien1997-06-24
MODEL 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S005)Covidien1995-12-28
MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S004)Covidien1995-06-14
MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S003)Covidien1994-06-17
MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S002)Covidien1994-03-28
MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S001)Covidien1993-09-10
MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034)Covidien1991-12-13