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)
Jan 27, 2009Ethicon Endo-Surgery Inc
Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 34 cm Curved Dissector Probe (Product Code EPS04)
Terminated
GCJK912492
Jan 27, 2009Ethicon Endo-Surgery Inc
Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 34 cm Right Angle Probe (Product Code EPS03)
Terminated
GCJK912492
Jan 27, 2009Ethicon Endo-Surgery Inc
Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 34 cm Spatula Probe (Product Code EPS02)
Terminated
GCJK912492
Jan 27, 2009Ethicon Endo-Surgery Inc
Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 34 cm Hook Probe (Product Code EPS01)
Terminated
GCJK912492
Dec 23, 2008CTS, Inc. dba Guidant Cardiac Surgery
VASOVIEW 4 Endoscopic Vessel Harvesting System, with VASOVIEW Flexible Endoscopic Tools in the following configurations: VH-10242: Uniport plus dissection cannula, short port blunt tip trocar, flexi
Terminated
GCJNone listed
Oct 24, 2008Stryker Endoscopy
26" Vision Elect HDTV Surgical Viewing Monitor, model number 0240030960, Manufactured by Stryker Endoscopy San Jose Intended to be used as a visualization device for events occurring in the sterile f
Terminated
GCJK935234
Oct 7, 2008Applied Medical Resources Corp
Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cann
Terminated
GCJK012884
Oct 7, 2008Applied Medical Resources Corp
Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation nee
Terminated
GCJK012884
Oct 7, 2008Applied Medical Resources Corp
Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Terminated
GCJK012884
Sep 29, 2008Stryker Communications Corp
OPHIT Optical Digital Visual Interface (DVI) Extender, Part number 0100224051, a component of the Switchpoint Infinity 1, Switchpoint Infinity 2, and Switchpoint Element. The OPHIT Optical Digital V
Terminated
GCJK033132
Aug 24, 2008Stryker Endoscopy
24mm Rotating C-Mount Coupler, Model Number 1088-020-121S2. The device in indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparos
Terminated
GCJK983566
Feb 2, 2008Conmed Corporation
POOLE Suction Instrument, Product Code: 0035040, 50/C. STERILE, EO, Rx ONLY. MANUFACTURED FOR CONMED CORPORATION, 310 Broad Street, Utica, NY 13501
Terminated
GCJNone listed
Feb 2, 2008Conmed Corporation
FRAZIER Olive Tip Suction Instrument, 10 French with Control Vent and Obturator, Product Code: 033110, 50/C. STERILE, EO, Rx ONLY. MANUFACTURED FOR CONMED CORPORATION, 310 Broad Street, Utica, NY 13
Terminated
GCJNone listed
Feb 2, 2008Conmed Corporation
FRAZIER Surgical Suction Instrument, 18 French with Obturator, Product Code: 0033180, 50/C. STERILE, EO, Rx ONLY. MANUFACTURED FOR CONMED CORPORATION, 310 Broad Street, Utica, NY 13501
Terminated
GCJNone listed
Feb 2, 2008Conmed Corporation
FRAZIER Surgical Suction Instrument, 12 French with Control Vent and Obturator, Product Code: 0033120, 50/C. STERILE, EO, Rx ONLY. MANUFACTURED FOR CONMED CORPORATION, 310 Broad Street, Utica, NY 135
Terminated
GCJNone listed
Feb 2, 2008Conmed Corporation
FRAZIER Surgical Suction Instrument, 10 French with Control Vent and Obturator, Product Code: 0033100, 50/C. STERILE, EO, Rx ONLY. MANUFACTURED FOR CONMED CORPORATION, 310 Broad Street, Utica, NY 1
Terminated
GCJNone listed
Feb 2, 2008Conmed Corporation
FRAZIER Surgical Suction Instrument, 8 French with Control Vent and Obturator, Product Code: 0033080, 50/C. STERILE, EO, Rx ONLY. MANUFACTURED FOR CONMED CORPORATION, 310 Broad Street, Utica, NY 13501
Terminated
GCJNone listed
Feb 2, 2008Conmed Corporation
FRAZIER Atraumatic Soft Tip Surgical Suction Instrument with Control Vent and Obturator, 10 French, Product Code: 0031100, 20/C. STERILE, EO, Rx ONLY. MANUFACTURED FOR CONMED CORPORATION, 310 Broad S
Terminated
GCJNone listed
Feb 2, 2008Conmed Corporation
FRAZIER Surgical Suction Instrument, 7 French with Control Vent and Obturator (Bend with Obturator in Place), Product Code: 0031070, 50/C. STERILE, EO, Rx ONLY. CONMED CORPORATION 310 Broad Street, Ut
Terminated
GCJNone listed
Feb 2, 2008Conmed Corporation
FRAZIER Surgical Suction Instrument, 5 French with Control Vent and Obturator, Product Code: 0031050, 50/C. STERILE, EO, Rx ONLY. MANUFACTURED FOR CONMED CORPORATION 310 Broad Street, Utica, NY 13501
Terminated
GCJNone listed
Feb 2, 2008Conmed Corporation
FRAZIER Surgical Suction Instrument, 3 French with Control and Obturator, Product Code: 0031030, 50/C. STERILE, EO, Rx ONLY. MANUFACTURED FOR CONMED CORPORATION, 310 Broad Street, Utica, NY 13501
Terminated
GCJNone listed
Jan 12, 2008Stryker Communications
Extron Electronics OEM, CAB, DVI-I to DVI (3ft.); Part #: 43-112-01 (Stryker Part #: 0100-224-108); Distributed by Stryker Communications, Flower Mound, TX 75028. (These cables are commonly used wit
Terminated
GCJK033132
Jan 12, 2008Stryker Communications
Extron Electronics OEM, CAB, DVI-Male to DVI-Female Cable Assembly (14 inch.); Part #: 43-111-01 (Stryker Part #: 0100-224-131); Distributed by Stryker Communications, Flower Mound, TX 75028. (These
Terminated
GCJK033132
Mar 13, 2007Conmed Corporation
POOLE Suction Instrument, REF 0035040. MANUFACTURED FOR CONMED CORPORATION, 310 Broad Street, Utica, NY 13501. ASSEMBLED IN MEXICO.
Terminated
GCJNone listed
Mar 13, 2007Conmed Corporation
FRAZIER Olive Tip Suction Instrument, 10 Fr. with Control Vent and Obturator (Bend with Obturator in Place), REF 0033110. MANUFACTURED FOR CONMED CORPORATION 310 Broad Street, Utica, NY 13501. ASSEMB
Terminated
GCJNone listed
Mar 13, 2007Conmed Corporation
FRAZIER Surgical Suction Instrument, 18 Fr. with Obturator, REF 0033180. MANUFACTURED FOR CONMED CORPORATION 310 Broad Street, Utica, NY 13501. ASSEMBLED IN MEXICO.
Terminated
GCJNone listed
Mar 13, 2007Conmed Corporation
FRAZIER Surgical Suction Instrument, 12 Fr. with Control Vent and Obturator, REF 0033120. MANUFACTURED FOR CONMED CORPORATION 310 Broad Street, Utica, NY 13501. ASSEMBLED IN MEXICO.
Terminated
GCJNone listed
Mar 13, 2007Conmed Corporation
FRAZIER Surgical Suction Instrument, 10 Fr. with Control Vent and Obturator, REF 0033100. MANUFACTURED FOR CONMED CORPORATION 310 Broad Street, Utica, NY 13501. ASSEMBLED IN MEXICO.
Terminated
GCJNone listed
Mar 13, 2007Conmed Corporation
FRAZIER Surgical Suction Instrument, 8 Fr. with Control Vent and Obturator, REF 0033080. MANUFACTURED FOR CONMED CORPORATION 310 Broad Street, Utica, NY 13501. ASSEMBLED IN MEXICO.
Terminated
GCJNone listed
Mar 13, 2007Conmed Corporation
FRAZIER Atraumatic Soft Tip Surgical Suction Instrument with Control Vent and Obturator, 10 French, REF 0031100. MANUFACTURED FOR CONMED CORPORATION 310 Broad Street, Utica, NY 13501. ASSEMBLED IN ME
Terminated
GCJNone listed
Mar 13, 2007Conmed Corporation
FRAZIER Surgical Suction Instrument, 7 Fr. with Control Vent and Obturator, REF 0031070. MANUFACTURED FOR CONMED CORPORATION 310 Broad Street, Utica, NY 13501. ASSEMBLED IN MEXICO.
Terminated
GCJNone listed
Mar 13, 2007Conmed Corporation
FRAZIER Surgical Suction Instrument, 5 Fr. with Control Vent and Obturator, REF 0031050. MANUFACTURED FOR CONMED CORPORATION 310 Broad Street, Utica, NY 13501.
Terminated
GCJNone listed
Mar 13, 2007Conmed Corporation
FRAZIER Surgical Suction Instrument, 3 Fr. with Control Vent and Obturator, REF 0031030. MANUFACTURED FOR CONMED CORPORATION 310 Broad Street, Utica, NY 13501. ASSEMBLED IN MEXICO.
Terminated
GCJNone listed
Jan 18, 2007Continental Medical Labs,Inc
Fibrin Analysis Catheter Testing System includes the component BD Vacutainer Luer-Lok Access Device; Catalogue #364902 as a finished sterile device, Non Pyrogenic in unopened undamaged package, Dispos
Terminated
GCJNone listed
Oct 27, 2006Conmed Corporation
ConMed Laparoscopic Instrument: Meeker (Right Angle) Disposable Dissector, 5mm x 43cm length, REF/Product Code 60-6040-434. --- The product is distributed sterile in heat-sealed tray and labeled with
Terminated
GCJK943327
Oct 27, 2006Conmed Corporation
ConMed Laparoscopic Instrument: Meeker (Right Angle) Disposable Dissector, 5mm x 33cm length, REF/Product Code 60-6040-004. --- The product is distributed sterile in heat-sealed tray and labeled with
Terminated
GCJK943327
Oct 27, 2006Conmed Corporation
ConMed Laparoscopic Instrument: Fenestrated (Duckbill) Disposable Dissector, 5mm x 43cm length, REF/Product Code 60-6040-433. --- The product is distributed sterile in heat-sealed tray and labeled wi
Terminated
GCJK943327
Oct 27, 2006Conmed Corporation
ConMed Laparoscopic Instrument: Fenestrated (Duckbill) Disposable Dissector, 5mm x 33cm length, REF/Product Code 60-6040-003. --- The product is distributed sterile in heat-sealed tray and labeled wi
Terminated
GCJK943327
Oct 27, 2006Conmed Corporation
ConMed Laparoscopic Instrument: Endoweave Disposable Dissector, 5mm x 43cm length, REF/Product Code 60-6040-435. --- The product is distributed sterile in heat-sealed tray and labeled with an expirati
Terminated
GCJK943327
Oct 27, 2006Conmed Corporation
ConMed Laparoscopic Instrument: Endoweave Disposable Dissector, 5mm x 33cm length, REF/Product Code 60-6040-005. --- The product is distributed sterile in heat-sealed tray and labeled with an expirat
Terminated
GCJK943327
Oct 27, 2006Conmed Corporation
ConMed Laparoscopic Instrument: Curved ''Maryland'' Disposable Dissector, 5mm x 43cm length, REF/Product Code 60-6040-432. --- The product is distributed sterile in heat-sealed tray and labeled with
Terminated
GCJK943327
Oct 27, 2006Conmed Corporation
ConMed Laparoscopic Instrument: Curved ''Maryland'' Disposable Dissector, 5mm x 33cm length, REF/Product Code 60-6040-002. --- The product is distributed sterile in heat-sealed tray and labeled with
Terminated
GCJK943327
Oct 27, 2006Conmed Corporation
ConMed Laparoscopic Instrument: Allis Disposable Dissector, 5mm x 43cm length, REF/Product Code 60-6040-436. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration d
Terminated
GCJK943327
Oct 27, 2006Conmed Corporation
ConMed Laparoscopic Instrument: Allis Disposable Dissector, 5mm x 33cm length, REF/Product Code 60-6040-006. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration d
Terminated
GCJK943327
Oct 27, 2006Conmed Corporation
ConMed Laparoscopic Instrument: Meeker (Right Angle) Disposable Grasper, 5mm x 43cm length, REF/Product Code 60-6045-434. --- The product is distributed sterile in heat-sealed tray and labeled with an
Terminated
GCJK943327
Oct 27, 2006Conmed Corporation
ConMed Laparoscopic Instrument: Meeker (Right Angle) Disposable Grasper, 5mm x 33cm length, REF/Product Code 60-6045-004. --- The product is distributed sterile in heat-sealed tray and labeled with an
Terminated
GCJK943327
Oct 27, 2006Conmed Corporation
ConMed Laparoscopic Instrument: Fenestrated (Duckbill) Disposable Grasper, 5mm x 43cm length, REF/Product Code 60-6045-433. --- The product is distributed sterile in heat-sealed tray and labeled with
Terminated
GCJK943327
Oct 27, 2006Conmed Corporation
ConMed Laparoscopic Instrument: Fenestrated (Duckbill) Disposable Grasper, 5mm x 33cm length, REF/Product Code 60-6045-003. --- The product is distributed sterile in heat-sealed tray and labeled with
Terminated
GCJK943327
Oct 27, 2006Conmed Corporation
ConMed Laparoscopic Instrument: Endoweave Disposable Grasper, 5mm x 43cm length, REF/Product Code 60-6045-435. --- The product is distributed sterile in heat-sealed tray and labeled with an expiratio
Terminated
GCJK943327
Oct 27, 2006Conmed Corporation
ConMed Laparoscopic Instrument: Endoweave Disposable Grasper, 5mm x 33cm length, REF/Product Code 60-6045-005. --- The product is distributed sterile in heat-sealed tray and labeled with an expiratio
Terminated
GCJK943327

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