ClearanceBrief
Panels › Gastroenterology, Urology › Product code GCJ · Class 2

Laparoscope, General & Plastic Surgery

Regulation 876.1500

28510(k)s in 12 months (1,431 all time)
2recalls in 12 months (274 all time)
215recalls that name a 510(k)
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Top companies in GCJ

DateFirm and productCodeLinked 510(k)
Jun 2, 2014Davol, Inc., Subs. C. R. Bard, Inc.
Bard Ventralight" ST Mesh with Echo PS TM 7"x9" Reorder Number: 5955790 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
Terminated
GCJK122436
Jun 2, 2014Davol, Inc., Subs. C. R. Bard, Inc.
Bard Ventralight" ST Mesh with Echo PS" 6"x8" Reorder Number: 5955680 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
Terminated
GCJK122436
Jun 2, 2014Davol, Inc., Subs. C. R. Bard, Inc.
Bard Ventralight" ST Mesh with Echo PS" 6"x10" Reorder Number: 5955610 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
Terminated
GCJK122436
Jun 2, 2014Davol, Inc., Subs. C. R. Bard, Inc.
Bard Ventralight" ST Mesh with Echo PS" 6" CircleReorder Number: 5955600 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
Terminated
GCJK122436
Jun 2, 2014Davol, Inc., Subs. C. R. Bard, Inc.
Bard Ventralight" ST Mesh with Echo PS" 4"x6" Reorder Number: 5955460 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
Terminated
GCJK122436
Jun 2, 2014Davol, Inc., Subs. C. R. Bard, Inc.
Bard Ventralight" ST Mesh with Echo PS" 4.5" Circle Reorder Number: 5955450 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
Terminated
GCJK122436
Jun 2, 2014Davol, Inc., Subs. C. R. Bard, Inc.
Bard Ventralight" ST Mesh with Echo PS" 12"x14" Reorder Number: 5955124 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
Terminated
GCJK122436
Jun 2, 2014Davol, Inc., Subs. C. R. Bard, Inc.
BardVentralight" ST Mesh with Echo PS" 10"x13" Reorder Number: 5955113 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
Terminated
GCJK122436
Jun 2, 2014Davol, Inc., Subs. C. R. Bard, Inc.
Bard Composix" LIP Mesh with Echo PS" 8"x10" Reorder Number: 0144810 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
Terminated
GCJK122436
Jun 2, 2014Davol, Inc., Subs. C. R. Bard, Inc.
Bard Composix" LIP Mesh with Echo PS" 7"x9" Reorder Number: 0144790 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
Terminated
GCJK122436
Jun 2, 2014Davol, Inc., Subs. C. R. Bard, Inc.
Composix" LP with Echo PS" 6x8 Reorder Number: 0144680 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
Terminated
GCJK122436
Jun 2, 2014Davol, Inc., Subs. C. R. Bard, Inc.
Composix" LP with Echo PS" 6x10 Reorder Number: 0144610 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
Terminated
GCJK122436
Jun 2, 2014Davol, Inc., Subs. C. R. Bard, Inc.
Composix" LP with Echo PS" 10x13 HUXH0294 HUXL0314 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
Terminated
GCJK122436
Apr 2, 2014Teleflex Medical
5/10 Weck Vista Universal Balloon Open Access Port - Standard Length (70mm), Catalog No. 410944, 5/10 Weck Vista Universal Balloon Open Access Port - Long Length (100mm), Catalog No. 410944L; 5/10 Wec
Terminated
GCJK112456
Apr 2, 2014Teleflex Medical
5/10/12 mm x 100mm Weck Vista Universal Cone Open Access, Catalog No. 405933. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of b
Terminated
GCJK021731
Apr 2, 2014Teleflex Medical
5/10 mm Weck Vista Universal Cannula, Catalog No. 405910RC; 5/10/12 mm Weck Vista Universal Cannula, Catalog No. 405912RC. An endoscope and accessories is a device used to provide access, illuminatio
Terminated
GCJK010007
Apr 2, 2014Teleflex Medical
5/10 mm Weck Vista Optical Bladeless Laparoscopic Access Port, Catalog No. 405910R; 5/10/12 mm Weck Vista Optical Bladeless Laparoscopic Access Port, Catalog No. 405912R. An endoscope and accessories
Terminated
GCJK121380
Apr 2, 2014Teleflex Medical
10mm Weck Vista Cannula-only, Catalog No. 405910C, 12mm Weck Vista Cannula-only, Catalog No. 405912C. An endoscope and accessories is a device used to provide access, illumination, and allow observat
Terminated
GCJK121796
Apr 2, 2014Teleflex Medical
Weck Vista Universal Laparoscopic Port, Size 5/10mm x 100mm, Catalog No. 405910, Weck Vista Universal Laparoscopic Port, Size 5/10/12mm x 100mm, Catalog No. 405912; Weck Vista Universal Laparoscopic P
Terminated
GCJK082156
Mar 25, 2014Teleflex Medical
5/10/12 Weck Vista" Universal Balloon Open Access Port Long Length (100mm), Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or m
Terminated
GCJK112456
Mar 25, 2014Teleflex Medical
5/10/12 Weck Vista" Universal Balloon Open Access Port Standard Length (70mm), Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation
Terminated
GCJK112456
Mar 25, 2014Teleflex Medical
5/10 Weck Vista" Universal Balloon Open Access Port Short Length (53mm), Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or man
Terminated
GCJK112456
Mar 25, 2014Teleflex Medical
5/10 Weck Vista" Universal Balloon Open Access Port - Long Length (100mm), Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or ma
Terminated
GCJK112456
Mar 25, 2014Teleflex Medical
5/10 Weck Vista" Universal Balloon Open Access Port - Standard Length (70mm), Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or
Terminated
GCJK112456
Mar 25, 2014Teleflex Medical
5/10/12MM X 100MM Weck Vista" UNIVERSAL CONE OPEN ACCESS, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of bod
Terminated
GCJK021731
Mar 25, 2014Teleflex Medical
5/10/12 mm Weck Vista" Universal Cannula, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollo
Terminated
GCJK010007
Mar 25, 2014Teleflex Medical
5/10/12 mm Weck Vista" Optical Bladeless Laparoscopic Access Port, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulati
Terminated
GCJK121380
Mar 25, 2014Teleflex Medical
12mm Weck Vista" Cannula-only, Teleflex Medical, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavitie
Terminated
GCJK121796
Mar 25, 2014Teleflex Medical
Weck Vista" Universal Laparoscopic Port, Size 5/10/12mmx125mm, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation o
Terminated
GCJK082156
Mar 25, 2014Teleflex Medical
Weck Vista" Universal Laparoscopic Port, Size 5/10/12mmx100mm, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation o
Terminated
GCJK082156
Mar 25, 2014Teleflex Medical
5/10 mm Weck, Vista" Universal Cannula, Teleflex Medical, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of bod
Terminated
GCJK010007
Mar 25, 2014Teleflex Medical
5/10 mm Weck, Vista" Optical Bladeless Laparoscopic Access Port, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation
Terminated
GCJK121380
Mar 25, 2014Teleflex Medical
10mm Weck Vista" Cannula-only, Teleflex Medical, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavitie
Terminated
GCJK121796
Mar 25, 2014Teleflex Medical
Weck Vista", Universal Laparoscopic Port, Size 5/10mmx100mm, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of
Terminated
GCJK082156
Feb 21, 2014Terumo Cardiovascular Systems Corporation
VirtuoSaph Plus Endoscopic Vessel Harvesting System, Part number: VSP550, Sterile***Rx Only*** Product Usage: The VirtuoSaph Plus Endoscopic Vessel Harvesting System is indicated for use in minimall
Terminated
GCJK092789
Jan 24, 2014Applied Medical Resources Corp
Applied Medical's Inzii 12/15mm Retrieval System. Applieds Inzii Tissue Retrieval Bag, Model Number CD004, is classified as a Class II device. It was cleared to market via 510(k) filing K060051. The
Terminated
GCJK060051
Dec 6, 2013Karl Storz Endoscopy America Inc
Axillent Debakey Grasping Forceps, Part No. 33821DYD In general the surgeons use 33821DYD Debakey forceps to grasp tissue.
Terminated
GCJK934937
Sep 21, 2013Endoplus, Inc.
ENDOPLUS; Precision Laparoscopic Instruments; REF 345VA; Description 5 mm Traumatic Grasper S/A, Standard; Non-sterile; Manufactured by Endoplus; 750 Tower Rd., Suite A, Mundelein, IL 60060 USA. In
Terminated
GCJK925079
Sep 21, 2013Endoplus, Inc.
ENDOPLUS; Precision Laparoscopic Instruments; REF 346VA; Description 5mm Atraumatic Grasper S/A, Standard; Non-sterile; Manufactured by Endoplus; 750 Tower Rd., Suite A, Mundelein, IL 60060 USA. In
Terminated
GCJK925079
Sep 9, 2013Xlumena, Inc.
Xlumena brand NAVIX Access Device, Model/Catalogue Number: NVX-10-03, Part Number: FG-00666, Product is manufactured and distributed by Xlumena, Inc., Mountain View, CA The NAVIX Access Device is a m
Terminated
GCJK093279
Jul 19, 2013Ethicon Endo-Surgery Inc
Endopath Electrosurgery Probe Plus II, twelve (12) different devices, including hooks, spatulas, right angles, curved dissectors, suction/irrigation devices, accessory ports, pool/sump devices and sto
Terminated
GCJK912492
Jun 5, 2013Covidien LP
Versaport Bladeless Optical Fixation Cannula - 5mm Product Code: ONBFCA5ST The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologi
Terminated
GCJK112349
Jun 5, 2013Covidien LP
Versaport Bladeless Optical Fixation Cannula - 5mm Short Product Code: ONBFCA5SH The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and
Terminated
GCJK112349
Jun 5, 2013Covidien LP
Versaport Bladeless Optical Trocar With (2) Fixation Cannulae - 5mm Product Code: ONB5STF2C The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, th
Terminated
GCJK112349
Jun 5, 2013Covidien LP
Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Product Code: ONB5STF The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic a
Terminated
GCJK112349
Jun 5, 2013Covidien LP
Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Short Product Code: ONB5SHF The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, tho
Terminated
GCJK112349
Jun 5, 2013Covidien LP
Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Long Product Code: ONB5LGF The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thor
Terminated
GCJK112349
Feb 14, 2013Lumenis Limited
The Lumenis VersaCut Tissue Morcellator Product Usage: is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparosc
Terminated
GCJK050639
Aug 3, 2012Transenterix, Inc
SPIDER Surgical Instrument: Flexible Clip Applier The SPIDER Surgical Instruments are intended for use in minimally invasive surgical procedures for grasping, mobilizing, dissecting, retracting, cutt
Terminated
GCJK091697
May 1, 2012Smith & Nephew, Inc. Endoscopy Division
Smith & Nephew 560P High Definition Camera Control Unit Catalog Number: 72201919 The 560P camera system is configured to be connected as a stand-alone system on an endoscopic cart or tower. It is desi
Terminated
GCJK070266

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