Atlas FDA

AUTO SUTURE SURGICAL STAPLES

FDA 510(k) clearance K013860 · decided 2001-12-19

Clearance details

K-number
K013860
Device name
AUTO SUTURE SURGICAL STAPLES
Applicant
United States Surgical, A Division of Tyco Healthc
Decision
Substantially Equivalent
Date received
2001-11-21
Decision date
2001-12-19
Days to decision
28 days
Clearance type
Special
Product code
GDW
Device class
2
Regulation number
878.4750
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Norwalk, CT, US
Third-party review
No
Expedited review
No

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RecordFirmDate
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Recalls involving this device

RecordFirmDate
Auto Suture TA 30 Reloadable Staplers, Single Patient Use Ref TA30V3S, V3 (2.5mm) DST Seri recall (Z-0958-04)United States Surgical2004-07-20
Auto SutureTA 30 Reloadable Stapler,Single Patient Use,3.5mm DST Series Ref: TA3035S recall (Z-0959-04)United States Surgical2004-07-20
Auto SutureTA 30 Reloadable Stapler,Single Patient Use, 4.8mm DST Series Ref: TA30348S recall (Z-0960-04)United States Surgical2004-07-20
Auto SutureTA 45 Reloadable Stapler,Single Patient Use, 3.5mm DST Series Ref: TA4535S recall (Z-0961-04)United States Surgical2004-07-20
Auto SutureTA 45 Reloadable Stapler,Single Patient Use, 4.8mm DST Series Ref: TA4548S recall (Z-0962-04)United States Surgical2004-07-20
Auto SutureTA 60 Reloadable Stapler,Single Patient Use, 3.5mm DST Series Ref: TA6035S recall (Z-0963-04)United States Surgical2004-07-20
Auto SutureTA 60 Reloadable Stapler,Single Patient Use, 4.8mm DST Series Ref: TA6048S recall (Z-0964-04)United States Surgical2004-07-20
Auto SutureTA 90 Reloadable Stapler,Single Patient Use, 4.8mm DST Series Ref: TA9048S recall (Z-0966-04)United States Surgical2004-07-20