ClearanceBrief
Panels › General Hospital › Product code GAG · Class 2

Stapler, Surgical

Regulation 878.4740

1510(k)s in 12 months (43 all time)
0recalls in 12 months (10 all time)
5recalls that name a 510(k)
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Top companies in GAG

Company510(k)sRecalls
Covidien52
Ethicon Endo-Surgery, Inc.52
ETHICON, Inc.60
Davis & Geck, Inc.40
American V. Mueller30
Intuitive Surgical, Inc.12
Surgeons Choice, Inc.30
Edward Weck, Inc.20
Lexington Medical, Inc.20
Power Medical Interventions02
DateFirm and productCodeLinked 510(k)
May 13, 2022Covidien, LP
EEA Autosuture Circular Stapler with DST Series Technology, 25mm. Model Numbers EEA25, EEAXL25, EEA2535, and EEAXL2535.
Open, Classified		 GAGNone listed
Jul 1, 2019Intuitive Surgical, Inc.
daVinci XI Sureform 60 Reload, 60 mm black 6-Row 4.6 mm, Ref: 48360T-08 , UDI: 00886874113851, Rx only, SterileEO - Product Usage: are intended to be used with da Vinci Surgical Systems for resection
Open, Classified		 GAGK173721
Jul 1, 2019Intuitive Surgical, Inc.
daVinci XI Sureform 60 reload, 60 mm Green 6- Row, 4.6 mm, REF 48360G-08, UDI: 00886874113844, Rx Only, Sterile EO - Product Usage: are intended to be used with da Vinci Surgical Systems for resectio
Open, Classified		 GAGK173721
Aug 17, 2018COVIDIEN LLC
EEA Circular Stapler with Tri-Staple Technology, Part No. TRIEEA28MT TRIEEA28XT TRIEEA31MT TRIEEA31XT Product Usage: The EEA Circular Stapler with Tri-Staple Technology places a circular, triple sta
Terminated		 GAGK172361
Sep 8, 2014Ethicon Endo-Surgery Inc
PROXIMATE Skin Stapler. PROXIMATE RH Rotating-Head Skin Stapler (Model PRR35), PROXIMATE PX Fixed-Head Skin Stapler (Model PXR35), Bulk/Non-Sterile PROXIMATE RH Rotating-Head Skin Stapler (Model C
Terminated		 GAGNone listed
Jul 1, 2013Surgical Instrument Service And Savings, Inc.
-ENDOPATH ETS-Flex Articulating Endoscopic Linear Cutter, (Blue) w/o Staples 35mm. REF ATB35 Lot 122300. -Ligaclip MCA Multiple Clip Applier, 20 Small Clips Small. REF MCS20 Lot 122300. - Ethicon P
Terminated		 GAGNone listed
Mar 7, 2013Ethicon Endo-Surgery Inc
PSX PROXIMATE Skin Staple Extractor, ETHICON ENDO-SURGERY, LLC. For routine skin closure in a wide variety of surgical procedures.
Terminated		 GAGNone listed
May 19, 2010Cardinal Health
Disposable Skin Stapler - 35 Wide; Surgical Skin Stapler; Rx, sterile, single use skin stapler, individually packaged in a thermo-formed tray with a Tyvek lid, 5 trays per box; Distributed by Cardinal
Terminated		 GAGNone listed
Jul 24, 2003Power Medical Interventions
SurgASSIST System. Circular Stapler DLU 33 mm (product code CS33).
Terminated		 GAGK003277
Jul 24, 2003Power Medical Interventions
SurgASSIST System. Circular Stapler DLU 29 mm (product code CS29)
Terminated		 GAGK003277

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