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)
Top companies in GCJ
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 2, 2014 | Davol, 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 |
GCJ | K122436 |
| Jun 2, 2014 | Davol, 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 |
GCJ | K122436 |
| Jun 2, 2014 | Davol, 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 |
GCJ | K122436 |
| Jun 2, 2014 | Davol, 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 |
GCJ | K122436 |
| Jun 2, 2014 | Davol, 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 |
GCJ | K122436 |
| Jun 2, 2014 | Davol, 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 |
GCJ | K122436 |
| Jun 2, 2014 | Davol, 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 |
GCJ | K122436 |
| Jun 2, 2014 | Davol, 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 |
GCJ | K122436 |
| Jun 2, 2014 | Davol, 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 |
GCJ | K122436 |
| Jun 2, 2014 | Davol, 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 |
GCJ | K122436 |
| Jun 2, 2014 | Davol, 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 |
GCJ | K122436 |
| Jun 2, 2014 | Davol, 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 |
GCJ | K122436 |
| Jun 2, 2014 | Davol, 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 |
GCJ | K122436 |
| Apr 2, 2014 | Teleflex 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 |
GCJ | K112456 |
| Apr 2, 2014 | Teleflex 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 |
GCJ | K021731 |
| Apr 2, 2014 | Teleflex 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 |
GCJ | K010007 |
| Apr 2, 2014 | Teleflex 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 |
GCJ | K121380 |
| Apr 2, 2014 | Teleflex 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 |
GCJ | K121796 |
| Apr 2, 2014 | Teleflex 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 |
GCJ | K082156 |
| Mar 25, 2014 | Teleflex 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 |
GCJ | K112456 |
| Mar 25, 2014 | Teleflex 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 |
GCJ | K112456 |
| Mar 25, 2014 | Teleflex 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 |
GCJ | K112456 |
| Mar 25, 2014 | Teleflex 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 |
GCJ | K112456 |
| Mar 25, 2014 | Teleflex 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 |
GCJ | K112456 |
| Mar 25, 2014 | Teleflex 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 |
GCJ | K021731 |
| Mar 25, 2014 | Teleflex 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 |
GCJ | K010007 |
| Mar 25, 2014 | Teleflex 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 |
GCJ | K121380 |
| Mar 25, 2014 | Teleflex 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 |
GCJ | K121796 |
| Mar 25, 2014 | Teleflex 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 |
GCJ | K082156 |
| Mar 25, 2014 | Teleflex 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 |
GCJ | K082156 |
| Mar 25, 2014 | Teleflex 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 |
GCJ | K010007 |
| Mar 25, 2014 | Teleflex 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 |
GCJ | K121380 |
| Mar 25, 2014 | Teleflex 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 |
GCJ | K121796 |
| Mar 25, 2014 | Teleflex 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 |
GCJ | K082156 |
| Feb 21, 2014 | Terumo 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 |
GCJ | K092789 |
| Jan 24, 2014 | Applied 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 |
GCJ | K060051 |
| Dec 6, 2013 | Karl Storz Endoscopy America Inc Axillent Debakey Grasping Forceps, Part No. 33821DYD
In general the surgeons use 33821DYD Debakey forceps to grasp tissue. Terminated |
GCJ | K934937 |
| Sep 21, 2013 | Endoplus, 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 |
GCJ | K925079 |
| Sep 21, 2013 | Endoplus, 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 |
GCJ | K925079 |
| Sep 9, 2013 | Xlumena, 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 |
GCJ | K093279 |
| Jul 19, 2013 | Ethicon 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 |
GCJ | K912492 |
| Jun 5, 2013 | Covidien 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 |
GCJ | K112349 |
| Jun 5, 2013 | Covidien 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 |
GCJ | K112349 |
| Jun 5, 2013 | Covidien 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 |
GCJ | K112349 |
| Jun 5, 2013 | Covidien 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 |
GCJ | K112349 |
| Jun 5, 2013 | Covidien 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 |
GCJ | K112349 |
| Jun 5, 2013 | Covidien 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 |
GCJ | K112349 |
| Feb 14, 2013 | Lumenis 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 |
GCJ | K050639 |
| Aug 3, 2012 | Transenterix, 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 |
GCJ | K091697 |
| May 1, 2012 | Smith & 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 |
GCJ | K070266 |
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