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)
Oct 28, 2011Stryker 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
GCJK033132
Oct 21, 2011Smith & Nephew, Inc. Endoscopy Division
Smith & Nephew, HD1200 Autoclavable Camera Head Catalog Number: 72203360 Product Usage: Endoscope & Accessories
Terminated
GCJK014158
Aug 24, 2011Applied 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
GCJK060096
Aug 24, 2011Applied 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
GCJK060096
Aug 24, 2011Applied 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
GCJK060096
Aug 24, 2011Applied 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
GCJK060096
Aug 10, 2011Applied 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
GCJNone listed
Aug 10, 2011Applied 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
GCJNone listed
Aug 10, 2011Applied 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
GCJNone listed
Jul 21, 2011Terumo 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
GCJK092789
Apr 8, 2011Transenterix, 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
GCJK102839
Apr 8, 2011Transenterix, 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
GCJK090902
Mar 7, 2011Anchor 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
GCJK061555
Mar 7, 2011Anchor 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
GCJK061555
Mar 3, 2011Applied 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
GCJNone listed
Mar 3, 2011Applied 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
GCJNone listed
Mar 3, 2011Applied 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
GCJNone listed
Mar 3, 2011Applied 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
GCJNone listed
Mar 3, 2011Applied 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
GCJNone listed
Mar 3, 2011Applied 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
GCJNone listed
Mar 3, 2011Applied 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
GCJNone listed
Mar 3, 2011Applied 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
GCJNone listed
Mar 3, 2011Applied 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
GCJNone listed
Mar 3, 2011Applied 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
GCJNone listed
Mar 3, 2011Applied 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
GCJNone listed
Mar 3, 2011Applied 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
GCJNone listed
Mar 3, 2011Applied 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
GCJNone listed
Mar 3, 2011Applied 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
GCJNone listed
Mar 3, 2011Applied 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
GCJNone listed
Mar 3, 2011Applied 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
GCJNone listed
Mar 3, 2011Applied 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
GCJNone listed
Mar 3, 2011Applied 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
GCJNone listed
Mar 3, 2011Applied 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
GCJNone listed
Feb 14, 2011Terumo 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
GCJK083194
Jan 19, 2011Stryker 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
GCJK935234
Dec 13, 2010CTS, 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
GCJK030512
Oct 1, 2010Olympus America Inc.
Camera Head OTV-S7H-1D-L08E and Camera Head OTV-S7H-1D-F08E (designed to be used with Olympus endoscopic equipment)
Terminated
GCJNone listed
Sep 29, 2010Stryker 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
GCJK053311
Sep 22, 2010Transenterix, INC
Spider Flex Monopolar Hook (Spider Surgical Instruments), TransEnterix, Inc., Durham, NC
Terminated
GCJK091697
Sep 19, 2010Gyrus 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
GCJK923945
Jun 23, 2010Teleflex 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
GCJK082156
Jun 15, 2010Stryker 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
GCJK033132
May 21, 2010Stryker 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
GCJK031068
K033132
May 21, 2010Stryker 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
GCJK031068
K033132
Sep 18, 2009Applied 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
GCJK060096
Jan 27, 2009Ethicon Endo-Surgery Inc
Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Needle Probe (Product Code EPS09)
Terminated
GCJK912492
Jan 27, 2009Ethicon Endo-Surgery Inc
Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Curved Dissector Probe (Product Code EPS08)
Terminated
GCJK912492
Jan 27, 2009Ethicon Endo-Surgery Inc
Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Right Angle Probe (Product Code EPS07)
Terminated
GCJK912492
Jan 27, 2009Ethicon Endo-Surgery Inc
Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Spatula Probe (Product Code EPS06)
Terminated
GCJK912492
Jan 27, 2009Ethicon Endo-Surgery Inc
Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Hook Probe (Product Code EPS05)
Terminated
GCJK912492

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