ClickClean
Medeon Biodesign, Inc.
MEDEON BIODESIGN, INC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3012452802 | 3012452802 | MEDEON BIODESIGN, INC | 1 | N | 2020-04-25 | 7F, 116, HouGang St., Taipei Taipei - District TW 11170 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 187832 | 1077364273 | K192891 | Laparoscope Lens Shield Device (LENS) | GCJ | 2019-11-07 |
| 187832 | 1731923608 | K170103 | Laparoscope Lens Shield Device (LENS) | GCJ | 2017-02-16 |
| 187832 | 1296067900 | K160172 | Laparoscope Lens Shield Device | GCJ | 2016-04-21 |
| 187832 | 1062531891 | K160117 | AbClose - Port Site Closure Device | OCW | 2016-09-09 |
| 187832 | 1351802498 | K151117 | Laparoscope Lens Shield Device | GCJ | 2015-08-20 |
Product Codes Associated With Registrations#
PMN#
AbClose - Port Site Closure Device
Medeon Biodesign, Inc.
Laparoscope Lens Shield Device (LENS)
Medeon Biodesign, Inc
Laparoscope Lens Shield Device (LENS)
Medeon Biodesign, Inc
AbClose - Port Site Closure Device
Medeon Biodesign, Inc
Laparoscope Lens Shield Device
Medeon Biodesign, Inc
Laparoscope Lens Shield Device
Medeon Biodesign, Inc
GUDID#
Cross-Seal - The Cross-Seal Device is composed of a Catheter, Suture Delivery System, and Handle.The Cross-Seal Device tracks over a standard 0.038” or 0.035” (minimum length 130 cm) guidewire. A hemostasis valve located in the middle of the CATHETER limits blood flow from the GUIDEWIRE PORT through the CATHETER with or without the guidewire in place. The SUTURE DELIVERY SYSTEM contains NEEDLES, LOCATOR WINGS, and the NEEDLE BARREL that control suture placement around the arteriotomy. The HANDLE contains the SLIDER, BLEEDING INDICATOR, PLUNGER, RESET 1 BUTTON (SLIDER RETRACTOR), and RESET 2 BUTTON (LOCATOR WINGS RETRACTOR). The SLIDER triggers a mechanism that opens the LOCATOR WINGS and creates a sandwich configuration to stabilize the delivery system within the vessel wall. The BLEEDING INDICATOR connects to a lumen that has an intraluminal port positioned at the distal end of the Suture Delivery System to allow bleeding back to ensure Suture Delivery System is positioned properly in the femoral artery. The NEEDLE BARREL keeps the Cross-Seal Device from moving deeper inside the vessel, stabilizes the device once the LOCATOR WINGS are opened and retrieves the disengaged suture-carried NEEDLES. The PLUNGER triggers the NEEDLES to deploy sutures and simultaneously close the LOCATOR WINGS. The GUIDEWIRE GUIDE is the feature at distal handle portion which allows physician to practice coaxial insertion of device along guidewire if necessary.
2022-02-01
Cross-Seal - The Cross-Seal Accessories (Cross-Seal Knot Tyer, Cross-Seal Knot Pusher, and Cross-Seal Suture Trimmer) are designed to tie the knots, position the knot to the top of the arteriotomy, and to trim the trailing limbs of the suture, respectively.
2022-02-01
AbClose - The AbClose Port Site Closure Device includes the following components: • One (1) Suture Passer • One (1) Suture Guide The AbClose - Port Site Closure Device is a sterile, single-use device, which includes one Suture Guide and one Suture Passer. The Suture Guide has two channels to direct the Suture Passer with suture strand into the Suture Catcher. The Suture Catcher grasps the end of the suture strand. By withdrawing the Suture Guide from the abdominal cavity after the sutures are deployed, the device automatically creates a loop for closure. At the end, any standard knot tying technique may be performed by the physician to close the incision.
2021-04-27
Medeon - The AbClose - Port Site Closure Device is a sterile, single-use device including 2 major components, Suture Guide and Suture Passer. The device is used with a commercially cleared suture, and is used as a manual instrument to pass needles with suture through soft tissues for suturing. The device is designed with a suture retrieval system for unassisted fascial closures, facilitating standard suture closure techniques. The Suture Guide is structured by a Handle and a Suture Catcher. The pyramid-shape Suture Catcher is controlled by a Push Button to fold the Suture Catcher into cylinder shape for insertion into the trocar wound. Once the Suture Guide is in position, Suture Catcher is expanded back to a pyramid shape to stabilize the device on the trocar wound site.The Suture Passer is a handheld suture grasping device designed to pass sutures through soft tissue. It features a Handle and a stainless steel Needle assembled with a Suture Shaft that grasps a suture. The Suture Passer is designed to work with the Suture Guide to penetrate through soft tissues and deploy suture ends into the Suture Catcher. Withdraw Suture Guide by fold the Suture Catcher into cylinder shape, the two suture ends are securely captured and are ready for user to type knots to close the trocar wound site. The AbClose - Port Site Closure Device is intended to be used by clinicians through prescription use only.
2017-01-16
ClickClean™ - The Laparoscope Lens Shield Device (LENS) is a laparoscopic accessory lens shielding device consisting of multi-lumen sheath that slides over the laparoscope. The sheath assembling consists of 2 concentric sheaths: one outer and one end-to-end connected inner sheaths. The outer sheath provides protection and cover for the inner sheath and shielding film. It is intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids.
2020-05-15
ClickClean™ - The Laparoscope Lens Shield Device (LENS) is a laparoscopic accessory lens shielding device consisting of multi-lumen sheath that slides over the laparoscope. The sheath assembling consists of 2 concentric sheaths: one outer and one end-to-end connected inner sheaths. The outer sheath provides protection and cover for the inner sheath and shielding film. It is intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids.
2020-05-15
ClickClean™ - The Laparoscope Lens Shield Device (LENS) is a laparoscopic accessory lens shielding device consisting of multi-lumen sheath that slides over the laparoscope. The sheath assembling consists of 2 concentric sheaths: one outer and one end-to-end connected inner sheaths. The outer sheath provides protection and cover for the inner sheath and shielding film. It is intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids.
2019-05-03
ClickClean™ - The Laparoscope Lens Shield Device (LENS) is a laparoscopic accessory lens shielding device consisting of multi-lumen sheath that slides over the laparoscope. The sheath assembling consists of 2 concentric sheaths: one outer and one end-to-end connected inner sheaths. The outer sheath provides protection and cover for the inner sheath and shielding film. It is intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids.
2019-05-03
ClickClean™ - The Laparoscope Lens Shield Device (LENS) is a laparoscopic accessory lens shielding device consisting of multi-lumen sheath that slides over the laparoscope. The sheath assembling consists of 2 concentric sheaths: one outer and one end-to-end connected inner sheaths. The outer sheath provides protection and cover for the inner sheath and shielding film. It is intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids.
2020-03-04
ClickClean™ - The Laparoscope Lens Shield Device (LENS) is a laparoscopic accessory lens shielding device consisting of multi-lumen sheath that slides over the laparoscope. The sheath assembling consists of 2 concentric sheaths: one outer and one end-to-end connected inner sheaths. The outer sheath provides protection and cover for the inner sheath and shielding film. It is intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids.
2020-03-04
ClickClean™ - The Laparoscope Lens Shield Device (LENS) is a laparoscopic accessory lens shielding device consisting of multi-lumen sheath that slides over the laparoscope. The sheath assembling consists of 2 concentric sheaths: one outer and one end-to-end connected inner sheaths. The outer sheath provides protection and cover for the inner sheath and shielding film. It is intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids.
2017-07-31
ClickClean™ - The Laparoscope Lens Shield Device (LENS) is a laparoscopic accessory lens shielding device consisting of multi-lumen sheath that slides over the laparoscope. The sheath assembling consists of 2 concentric sheaths: one outer and one end-to-end connected inner sheaths. The outer sheath provides protection and cover for the inner sheath and shielding film. It is intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids.
2018-11-20
ClickClean™ - The Laparoscope Lens Shield Device (LENS) is a laparoscopic accessory lens shielding device consisting of multi-lumen sheath that slides over the laparoscope. The sheath assembling consists of 2 concentric sheaths: one outer and one end-to-end connected inner sheaths. The outer sheath provides protection and cover for the inner sheath and shielding film. It is intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids.
2018-12-24
ClickClean™ - The Laparoscope Lens Shield Device (LENS) is a laparoscopic accessory lens shielding device consisting of multi-lumen sheath that slides over the laparoscope. The sheath assembling consists of 2 concentric sheaths: one outer and one end-to-end connected inner sheaths. The outer sheath provides protection and cover for the inner sheath and shielding film. It is intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids.
2017-07-31
ClickClean™ - The Laparoscope Lens Shield Device (LENS) is a laparoscopic accessory lens shielding device consisting of multi-lumen sheath that slides over the laparoscope. The sheath assembling consists of 2 concentric sheaths: one outer and one end-to-end connected inner sheaths. The outer sheath provides protection and cover for the inner sheath and shielding film. It is intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids.
2018-11-20
ClickClean™ - The Laparoscope Lens Shield Device (LENS) is a laparoscopic accessory lens shielding device consisting of multi-lumen sheath that slides over the laparoscope. The sheath assembling consists of 2 concentric sheaths: one outer and one end-to-end connected inner sheaths. The outer sheath provides protection and cover for the inner sheath and shielding film. It is intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids.
2018-12-24