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) |
|---|---|---|---|
| Oct 28, 2011 | Stryker Communications Corp Stryker Communications, 1410 Lakeside Parkway, # 100, Flower Mound, TX 75208
Stryker EDS (Equipment Delivery System) Booms and Flat Panel Suspensions are intended for use as ceiling-mounted devices t Terminated |
GCJ | K033132 |
| Oct 21, 2011 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew, HD1200 Autoclavable Camera Head
Catalog Number: 72203360
Product Usage: Endoscope & Accessories Terminated |
GCJ | K014158 |
| Aug 24, 2011 | Applied Medical Resources Corp Applied Medical 15x100 mm Kii Optical Access Systems, Non-Threaded 6/Box, Model C0R39
Product Usage: Applied Medical's C0R36, C0R37, C0R38, and C0R39 trocars are diposable single-use devices indica Terminated |
GCJ | K060096 |
| Aug 24, 2011 | Applied Medical Resources Corp Applied Medical 15x100 mm Kii Optical Access Systems, Non-Threaded 6/Box, Model C0R38
Product Usage: Applied Medical's C0R36, C0R37, C0R38, and C0R39 trocars are diposable single-use devices indica Terminated |
GCJ | K060096 |
| Aug 24, 2011 | Applied Medical Resources Corp Applied Medical 15x100 mm Kii Optical Access Systems, Non-Threaded 6/Box, Model C0R37
Product Usage: Applied Medical's C0R36, C0R37, C0R38, and C0R39 trocars are diposable single-use devices indica Terminated |
GCJ | K060096 |
| Aug 24, 2011 | Applied Medical Resources Corp Applied Medical 15x100 mm Kii Optical Access Systems, Non-Threaded 6/Box, Model C0R36
Product Usage: Applied Medical's C0R36, C0R37, C0R38, and C0R39 trocars are diposable single-use devices indica Terminated |
GCJ | K060096 |
| Aug 10, 2011 | Applied Medical Resources Corp Direct Drive Grasper, VARIOUS KITS CONTAINING EITHER C4130
OR C4140
Intended Usage: The grasper is indicated for grasping and manipulating tissue during general or laparoscopic surgery. The instrume Terminated |
GCJ | None listed |
| Aug 10, 2011 | Applied Medical Resources Corp Direct Drive Grasper, Model number C4140, 5MM X 45CM DIRECT DRIVE
GRASPER 10/BX
Intended Usage: The grasper is indicated for grasping and manipulating tissue during general or laparoscopic surgery. Terminated |
GCJ | None listed |
| Aug 10, 2011 | Applied Medical Resources Corp Direct Drive Grasper, Model numbers C4130, 5MM X 35CM DIRECT DRIVE GRASPER 10/BX
Intended Usage: The grasper is indicated for grasping and manipulating tissue during general or laparoscopic surgery. Terminated |
GCJ | None listed |
| Jul 21, 2011 | Terumo Cardiovascular Systems Corporation VirtuoSaph Plus Endoscopic Vessel Harvesting System , REF VSP550, Sterile, Terumo Cardiovascular System
Indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is Terminated |
GCJ | K092789 |
| Apr 8, 2011 | Transenterix, Inc SPIDER ADVANCED Surgical Platform
The SPIDER is a single port, single incision device to facilitate multi-instrument access during laparoscopic surgical procedures. The SPIDER device is provided pre-s Terminated |
GCJ | K102839 |
| Apr 8, 2011 | Transenterix, Inc SPIDER Surgical Platform
The SPIDER is a single port, single incision device to facilitate multi-instrument access during laparoscopic surgical procedures. The SPIDER device is provided pre-steriliz Terminated |
GCJ | K090902 |
| Mar 7, 2011 | Anchor Products Company, Inc. Anchor Tissue Retrieval System; ETO sterilized, single use disposable device; port size 15 mm, 1550 mL capacity; 3 units per box; Manufacturer: Anchor Products Co., 52 Official Rd, Addison, IL 60101 U Terminated |
GCJ | K061555 |
| Mar 7, 2011 | Anchor Products Company, Inc. Anchor Tissue Retrieval System; ETO sterilized, single use disposable device; port size 10 mm, 225 mL capacity; 3 units per box; Manufacturer: Anchor Products Co., 52 Official Rd, Addison, IL 60101 U. Terminated |
GCJ | K061555 |
| Mar 3, 2011 | Applied Medical Resources Corp Applied Medical's KW/MOH LAP CHOLE KIT; Model Number: K2184
The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures. Terminated |
GCJ | None listed |
| Mar 3, 2011 | Applied Medical Resources Corp Applied Medical's LAP CHOLE ; Model Number: K2155
The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures. Terminated |
GCJ | None listed |
| Mar 3, 2011 | Applied Medical Resources Corp Applied Medical's LAP CHOLE KIT; Model Number: K2154
The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures. Terminated |
GCJ | None listed |
| Mar 3, 2011 | Applied Medical Resources Corp Applied Medical's PREMIUM DISPOSABLE LAP CHOLE KIT; Model Number: K2136
The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedu Terminated |
GCJ | None listed |
| Mar 3, 2011 | Applied Medical Resources Corp Applied Medical's LAP CHOLE KIT ; Model Number: K2114
The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures. Terminated |
GCJ | None listed |
| Mar 3, 2011 | Applied Medical Resources Corp Applied Medical's LAP CHOLE KIT ; Model Number: K0684
The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures. Terminated |
GCJ | None listed |
| Mar 3, 2011 | Applied Medical Resources Corp Applied Medical's LAP CHOLE KIT ; Model Number: K0630
The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures. Terminated |
GCJ | None listed |
| Mar 3, 2011 | Applied Medical Resources Corp Applied Medical's LAP CHOLE KIT - BLADED; Model Number: K0552
The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures. Terminated |
GCJ | None listed |
| Mar 3, 2011 | Applied Medical Resources Corp Applied Medical's LAP CHOLE KIT - 1A; Model Number: K0522
The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures. Terminated |
GCJ | None listed |
| Mar 3, 2011 | Applied Medical Resources Corp Applied Medical's AM CHOLE KIT-TAM1; Model Number: K0509
The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures. Terminated |
GCJ | None listed |
| Mar 3, 2011 | Applied Medical Resources Corp Applied Medical's LAP CHOLE KIT ; Model Number: K0492
The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures. Terminated |
GCJ | None listed |
| Mar 3, 2011 | Applied Medical Resources Corp Applied Medical's LAP CHOLE KIT ; Model Number: K0491
The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures. Terminated |
GCJ | None listed |
| Mar 3, 2011 | Applied Medical Resources Corp Applied Medical's LAP CHOLE KIT 16 GK; Model Number: GK116
The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures. Terminated |
GCJ | None listed |
| Mar 3, 2011 | Applied Medical Resources Corp Applied Medical's LAP CHOLE KIT 9 GK; Model Number: GK109-H
The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures. Terminated |
GCJ | None listed |
| Mar 3, 2011 | Applied Medical Resources Corp Applied Medical's LAP CHOLE KIT 8 GK; Model Number: GK108
The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures. Terminated |
GCJ | None listed |
| Mar 3, 2011 | Applied Medical Resources Corp Applied Medical's LAP CHOLE KIT 7 GK; Model Number: GK107
The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures. Terminated |
GCJ | None listed |
| Mar 3, 2011 | Applied Medical Resources Corp Applied Medical's LAP CHOLE KIT 5 GK; Model Number: GK105
The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures. Terminated |
GCJ | None listed |
| Mar 3, 2011 | Applied Medical Resources Corp Applied Medical's GELPOINT LAP CHOLE KIT 2; Model Number: CK102
The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures. Terminated |
GCJ | None listed |
| Mar 3, 2011 | Applied Medical Resources Corp Applied Medical's Direct Drive Laparoscopic Clip Applier; Model Number: CA090
The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical p Terminated |
GCJ | None listed |
| Feb 14, 2011 | Terumo Cardiovascular Systems Corporation Bipolar cord for use with the VirtuoSaph Endoscopic Vein Harvesting System, MCBICORD1, Terumo Cardiovascular System, Ann Arbor, MI.
The Terumo Bipolar cord MCBICORD1 is a flexible, reusable power cabl Terminated |
GCJ | K083194 |
| Jan 19, 2011 | Stryker Endoscopy Stryker brand Cart with Isolation Transformer,
Model Numbers: 240-099-001, 240-099-001K, 240-099-011, 240-099-011K, 240-099-020, 240-099-020K, 240-099-050, 240-099-072.
240-099-001,
240-099-001K,
24 Terminated |
GCJ | K935234 |
| Dec 13, 2010 | CTS, Inc. dba Guidant Cardiac Surgery Heartstring II Proximal Seal / VASOVIEW 6 Endoscopic Vessel Harvesting System,
Model Number: VH-2000,
Product is manufactured and distributed by Maquet Corporation
San Jose, CA Terminated |
GCJ | K030512 |
| Oct 1, 2010 | Olympus America Inc. Camera Head OTV-S7H-1D-L08E and Camera Head OTV-S7H-1D-F08E (designed to be used with Olympus endoscopic equipment) Terminated |
GCJ | None listed |
| Sep 29, 2010 | Stryker Endoscopy Stryker Scope Warmer, disposable. Endoscopic accessory composed of polyvinyl Chloride (PVC) and Sodium Acetate, Model Number 502-360-000, manufactured by Stryker Endoscopy, San Jose, CA. Terminated |
GCJ | K053311 |
| Sep 22, 2010 | Transenterix, INC Spider Flex Monopolar Hook (Spider Surgical Instruments), TransEnterix, Inc., Durham, NC Terminated |
GCJ | K091697 |
| Sep 19, 2010 | Gyrus Acmi, Incorporated The Gyrus ACMI Pleatman Sac Tissue Removal System facilitates removal of specimens while minimizing contamination of the abdominal cavity or wound tract. The system contains one (1) Sac and one (1) Terminated |
GCJ | K923945 |
| Jun 23, 2010 | Teleflex Medical TAUT ADAPt Balloon Open Access Port And Syringe 10/12mm x 100mm, REF 41244, Rx Only, Sterile, Teleflex Medical, Research Triangle Park, NC 27709.
Intended use: The ADAPt Balloon Open Access Port is Terminated |
GCJ | K082156 |
| Jun 15, 2010 | Stryker Communications Corp The SwitchPoint Infinity 2 (SPI2) and SwitchPoint Element (SPE), an integrated voice, video, data router and teleconferencing interface for the operating room.
The SwitchPoint Infinity 2 (SPI2) and S Terminated |
GCJ | K033132 |
| May 21, 2010 | Stryker Communications Corp SwitchPoint Infinity (SPI) Control System. Catalog Numbers: 067000220, 067000230, 067000231, 067000232, & 067000233.
Used for direct control of room equipment, audio/video equipment, and indirect co Terminated |
GCJ | K031068 K033132 |
| May 21, 2010 | Stryker Communications Corp SwitchPoint Element (SPE) Control System. Control System for audio/video, surgical, and room equipment. Catalog Numbers: 067000220, 067000230, 067000231, 067000232, 067000233.
Used for direct contr Terminated |
GCJ | K031068 K033132 |
| Sep 18, 2009 | Applied Medical Resources Corp Applied Medical 15x100mm Kii Optical Access System, Non-Threaded 6/Box, Model Number: C0R36, Labeled Sterile.
Disposable single-use devices indicated for use in general, abdominal, gynecological and Terminated |
GCJ | K060096 |
| Jan 27, 2009 | Ethicon Endo-Surgery Inc Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Needle Probe (Product Code EPS09) Terminated |
GCJ | K912492 |
| Jan 27, 2009 | Ethicon Endo-Surgery Inc Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Curved Dissector Probe (Product Code EPS08) Terminated |
GCJ | K912492 |
| Jan 27, 2009 | Ethicon Endo-Surgery Inc Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Right Angle Probe (Product Code EPS07) Terminated |
GCJ | K912492 |
| Jan 27, 2009 | Ethicon Endo-Surgery Inc Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Spatula Probe (Product Code EPS06) Terminated |
GCJ | K912492 |
| Jan 27, 2009 | Ethicon Endo-Surgery Inc Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Hook Probe
(Product Code EPS05) Terminated |
GCJ | K912492 |
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