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) |
|---|---|---|---|
| Mar 7, 2022 | Stryker Corporation 1688 Camera Control Unit (CCU), Catalog number:1688010000. Used in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope/endoscope/arthroscope/s Open, Classified |
GCJ | K182160 |
| Jun 15, 2021 | Baxter Healthcare Corporation EASYGRIP FLO-41 US. For delivering hemostatic agents to bleeding sites through a trocar. Terminated |
GCJ | K193137 |
| Feb 26, 2021 | Stryker Corporation Stryker, REF PC9001, PINPOINT Video Processor/Illuminator, Rx Only CE 0197, MD Medical Device, UDI: (01) 00858701006049 - Product Usage: used with both the SPY-PHI and PINPOINT systems, the intended u Terminated |
GCJ | K150956 |
| Feb 8, 2021 | Sharp Medical Products SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult Terminated |
GCJ | K150549 |
| Mar 23, 2020 | Olympus Corporation of the Americas Olympus Pleuravideoscope, Model LTF-240 Terminated |
GCJ | K013617 |
| Mar 23, 2020 | Olympus Corporation of the Americas Olympus Pleuravideoscope, Model LTF-160 Terminated |
GCJ | K013617 |
| Mar 21, 2019 | Conmed Corporation ConMed Anchor Tissue Retrieval System", 12 MM, 300 ML (5/BX)
Catalog Number: TRS-ROBO-12
The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer Terminated |
GCJ | K172940 |
| Mar 21, 2019 | Conmed Corporation ConMed Anchor Tissue Retrieval System, 8 MM, 125 ML (5/BX)
Catalog Number:TRS-ROBO-8
The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer for Terminated |
GCJ | K172940 |
| Mar 21, 2019 | Conmed Corporation ConMed Anchor Tissue Retrieval System, VATS, 15 MM, 1550 ML (3/BX)
Catalog Number: TRS-VATS-15
The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated intro Terminated |
GCJ | K172940 |
| Mar 21, 2019 | Conmed Corporation ConMed Anchor Tissue Retrieval System, 15 MM, 1850 ML (3/BX)
Catalog Number:TRS190SB2
The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer for Terminated |
GCJ | K172940 |
| Mar 21, 2019 | Conmed Corporation ConMed Anchor Tissue Retrieval System 15 MM, 1550 ML (3/BX)
Catalog Number: TRS175SB2
The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer for Terminated |
GCJ | K172940 |
| Mar 21, 2019 | Conmed Corporation ConMed Anchor Tissue Retrieval System 10 MM, 235 ML, (5/BX)
Catalog Number: TRS100SB2
The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer for Terminated |
GCJ | K172940 |
| Jan 28, 2019 | Applied Medical Resources Corp Kii Fios First Entry, 5 X 75 mm, RX only, REF CFF05 Qty: 6, Sterile R, Lot: 1330981, Exp: July 15, 2021, Applied Medical Resource Corp.
Product Usage:
Kii Fios first entry is indicated for use in g Terminated |
GCJ | K041795 K083638 |
| Jun 27, 2018 | Genicon, Inc. Genicon EZee Single Use Specimen Retrieval Bag - Product Usage: This device is disposable and is packaged and sterilized for single use only. The bag may be used for multiple specimen retraction. Open, Classified |
GCJ | K180579 |
| Jun 20, 2018 | Espiner Medical Ltd Espiner Tissue Retrieval System-Eco-Sac
Trocar 12mm Vol: 1200 ml
EMP160ECO-US-5 (GTIN:5060358120367)
Product Usage:
Tissue Retrieval sac made from ripstop nylon. The EMP160ECO-US-5 is a semi-automat Terminated |
GCJ | K111845 |
| Mar 26, 2018 | Ethicon Endo-Surgery Inc 5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 75mm shaft length, 2CB5ST Terminated |
GCJ | K032676 |
| Mar 26, 2018 | Ethicon Endo-Surgery Inc 5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 100mm shaft length, 2CB5LT Terminated |
GCJ | K032676 |
| Mar 26, 2018 | Ethicon Endo-Surgery Inc 5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 150mm shaft length, 2B5XT Terminated |
GCJ | K032676 |
| Mar 26, 2018 | Ethicon Endo-Surgery Inc 5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 75mm shaft length, 2B5ST Terminated |
GCJ | K032676 |
| Mar 26, 2018 | Ethicon Endo-Surgery Inc 5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 100mm shaft length, 2B5LT Terminated |
GCJ | K032676 |
| Nov 17, 2017 | Stryker Corporation StrykeFlow 2 System, labeled sterile. Includes the following:
a. STRYKER LAPAROSCOPIC SUCTION IRRIGATOR, Suction/Irrigator 2 (Model 0250070500);
b. STRYKER STRYKEFLOW SUCTION IRRIGATOR, Disposabl Terminated |
GCJ | K934094 K954726 |
| Jul 19, 2017 | Genicon, Inc. GENICON EZEE Retrieval, sterile, Rx only. Terminated |
GCJ | K162059 |
| Jun 14, 2017 | Applied Medical Resources Corp Kii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and
Kii 5x55mm Optical Z-Thread Dual Pack (CTR14) trocars. Terminated |
GCJ | K060096 K072674 |
| May 9, 2017 | Covidien LLC Covidien Endo Peanut 5mm Auto Suture Blunt Dissector
Item Code: 173019
The instrument has indications in endoscopic surgery for swabbing small amounts of fluid or for blunt dissection of soft tissue Terminated |
GCJ | K931962 |
| May 1, 2017 | Cook Inc. LapSac Introducer Set, Bag, Extraction, Supplied sterilized by ethylene oxide gas in peel-open packages.
Used to aid in the introduction of a LapSac during endoscopic surgical procedures. Terminated |
GCJ | None listed |
| May 1, 2017 | Cook Inc. LapSac Introducer, Supplied sterilized by ethylene oxide gas in peel-open packages.
Used to aid in the introduction of a LapSac during endoscopic surgical procedures. Terminated |
GCJ | None listed |
| Mar 8, 2017 | US Endoscopy Group Inc Roth Net Polyp Retrieval Terminated |
GCJ | K122462 |
| Oct 7, 2016 | Teleflex Medical Teleflex Percuaneous Solutions, Johans Grasper, Ref ML004EE, Rx Only Sterile Manufactured for: Teleflex Medical, Park, NC 27709
The Percutaneous Surgical System with 5 mm attachments is indicated for Terminated |
GCJ | K143299 |
| Oct 7, 2016 | Teleflex Medical Teleflex Percuaneous Solutions, Gripper Grasper, Ref ML003EE, Rx Only Sterile Manufactured for: Teleflex Medical, Park, NC 27709
The Percutaneous Surgical System with 5 mm attachments is indicated fo Terminated |
GCJ | K143299 |
| Sep 7, 2016 | Banyan Medical, LLC Banyan Medical 5 x 55mm Pyramidal Tip Trocar w/ 2X Cannula w/
Sideport. Laproscopic Use- Sterile Single Use Only
Product Code 400-009 Terminated |
GCJ | K133375 |
| Sep 7, 2016 | Banyan Medical, LLC Banyan Medical 5 x 55mm Regular Pyramidal Trocar and 2x Cannula.
For Laproscopic Use- Sterile Single Use Only.
Product Code 400-008 Terminated |
GCJ | K133375 |
| Jul 23, 2016 | Pentax Medical Company Confocal GI Scope
Product Usage:
Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissue Terminated |
GCJ | K042741 |
| Jul 22, 2016 | Carefusion 2200 Inc DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date Code: C16.
Designed to retract or elevate organs and tissue to provide better v Terminated |
GCJ | K092684 |
| Jun 28, 2016 | Pentax Medical Company Confocal GI Scope
Intended to provide optical visualization of an therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Terminated |
GCJ | K042741 |
| Jan 29, 2016 | Novadaq Technologies Inc. PINPOINT Endoscopic Fluorescence Imaging System Terminated |
GCJ | K091515 |
| Sep 16, 2015 | Lumenis Lumenis VersaCut+ Tissue Morcellator GA-0007500
The Lumenis VersaCut / VersaCut+ Tissue Morcellator System is intended for use under direct or endoscopic visualization for the morcellation and remova Terminated |
GCJ | K133272 |
| Jul 24, 2015 | EXP Pharmaceutical Services Corp Medical Device Exchange - Dilating Tip Trocar w/Stability Sleeve 12mm;
Pouch, Tyvek/Mylar, Sterile, Single Use Only;
OEM Catalog number D12LT;
EXP (repackager), Ethicon (OEM)
Laparoscope, General & Terminated |
GCJ | None listed |
| Jul 24, 2015 | EXP Pharmaceutical Services Corp Medical Device Exchange - Dilating Tip Trocar w/Stability Sleeve 11mm;
Pouch, Tyvek/Mylar, Sterile, Single Use Only;
OEM Catalog number D11LT;
EXP (repackager), Ethicon (OEM)
Laparoscope, General & Terminated |
GCJ | None listed |
| Jul 24, 2015 | EXP Pharmaceutical Services Corp Medical Device Exchange - Versaport Bladeless Trocar w/ Fixation
Cannula 5mm;
Pouch, Tyvek/Mylar, Sterile, Single Use Only;
OEM Catalog number NB5STF;
EXP (repackager), Covidien (OEM)
Laparoscope, Terminated |
GCJ | None listed |
| Jul 24, 2015 | EXP Pharmaceutical Services Corp Medical Device Exchange - Trocar VersaPort Plus V2; 5mm -11mm;
Pouch, Tyvek/Mylar, Sterile, Single Use Only;
OEM Catalog number 179095P;
EXP (repackager), Auto Suture (OEM)
Laparoscope, General and Terminated |
GCJ | None listed |
| Jul 24, 2015 | EXP Pharmaceutical Services Corp Medical Device Exchange - KII FIOS FIRST ENTRY 5X100MM;
Pouch, Tyvek/Mylar, Sterile, Single Use Only;
OEM Catalog number CFF03
EXP (repackager), Applied Medical (OEM)
Laparoscope, General & Plastic Terminated |
GCJ | None listed |
| Jul 24, 2015 | EXP Pharmaceutical Services Corp Medical Device Exchange - GelPort Laparoscopic System;
Pouch, Tyvek/Mylar, Sterile, Single Use Only;
OEM Catalog number C8XX2N0NCE.
EXP (repackager), Applied Medical (OEM)
Laparoscope, General & Pl Terminated |
GCJ | None listed |
| May 21, 2015 | DeRoyal Industries Inc DeRoyal(R) Medium Specimen Retrieval Bag, REF 5500-000-003, Rx Only
Product Usage: The device is a single-use specimen retrieval bag indicated for use in laparoscopic procedures to capture and remo Terminated |
GCJ | K132375 |
| Dec 19, 2014 | Intuitive Surgical, Inc. Fluorescence Imaging Procedure Kit, designed
for use with Firefly Fluorescence Imaging for the da Vinci Xi 4000 Surgical Systems. The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Terminated |
GCJ | K141077 |
| Dec 19, 2014 | Intuitive Surgical, Inc. Fluorescence Imaging Procedure Kit, designed
for use with Firefly Fluorescence Imaging for the da Vinci Si 3000 Surgical Systems. The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Terminated |
GCJ | K101077 |
| Dec 12, 2014 | Stryker Endoscopy 1488 HD 3-Chip Camera;
Model Number 1488-610-122 - HD 3-Chip Camera Head with Integrated Coupler.
Product Usage: High definition camera to view endoscopic surgical sites on video monitors and captur Terminated |
GCJ | K132785 |
| Dec 12, 2014 | Stryker Endoscopy 1488 HD 3-Chip Inline Camera;
Model Number 1488-710-105 - HD 3-Chip Inline Camera, C-Mount;
Product Usage: High definition camera to view endoscopic surgical sites on video monitors and capture stil Terminated |
GCJ | K132785 |
| Dec 12, 2014 | Stryker Endoscopy 1488 HD 3-Chip Camera;
Model Number 1488-210-105 - C-Mount.
Product Usage: High definition camera to view endoscopic surgical sites on video monitors and capture still and video images of endoscopi Terminated |
GCJ | K132785 |
| Jun 2, 2014 | Davol, Inc., Subs. C. R. Bard, Inc. Bard Ventralight" ST Mesh with Echo PS" 8"x10" Reorder Number: 5955810
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" 8" Circle Number: 5955800
Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. Terminated |
GCJ | K122436 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.