Company
US Endoscopy Group Inc
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
10recalls (0 in 12 months)
10recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KOG | 2 | |
| OCX | Endoscopic Irrigation/Suction System | 2 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 1 |
| FDI | Snare, Flexible | 1 |
| FGO | Dislodger, Stone, Flexible | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 |
| OCZ | Endoscopic Grasping/Cutting Instrument, Non-Powered | 1 |
| PKL | Hemostatic Metal Clip For The Gi Tract | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 4, 2019 | US Endoscopy Group Inc US Endoscopy Padlock Clip defect closure system
Ref: C910001
The Padlock Clip is indicated for use in flexible endoscopy and for the compression of tissue in the gastrointestinal tract, for hemostas Terminated |
PKL | K120814 |
| Mar 8, 2017 | US Endoscopy Group Inc Roth Net Polyp Retrieval Terminated |
GCJ | K122462 |
| Oct 19, 2016 | US Endoscopy Group Inc Vari-Safe Injection Needle US endoscopy 5976 Heisley Road Mentor, Ohio 44060
A sterile, single use, flexible sheath device intended to be used for the injection of various types of media through flex Terminated |
FBK | K971842 |
| Oct 1, 2015 | US Endoscopy Group Inc Histolock Resection Device, US Endoscopy.
An electrosurgical device designed to be used to endoscopically grasp, dissect and transect tissue during gastrointestinal endoscopic procedures. Terminated |
FDI | K140763 |
| Jul 1, 2015 | US Endoscopy Group Inc Velocity" Biopsy Valve, 25 units per box,
Product Usage:
The disposable Velocity biopsy valve is used to cover the opening of the biopsy inlet port of a flexible gastrointestinal endoscope. The Velo Terminated |
OCX | K092461 |
| Apr 16, 2015 | US Endoscopy Group Inc Talon Grasping Device, 160 cm, US endoscopy. Used for retrieval of foreign bodies, tissue specimens, stones or calculi in endoscopic procedures of the gastrointestinal tract. Terminated |
OCZ | K962676 |
| Dec 23, 2014 | US Endoscopy Group Inc UroSeal Adjustable Endoscopic Valve. Model/Catalog # 00913410
The primary packaging is a Tyvek pouch. The secondary package is a corrugate box. 5 units per box.
Used to cover the opening to the bi Terminated |
KOG | K070420 |
| Apr 11, 2013 | US Endoscopy Group Inc Torrent" irrigation tubing.
Product Usage: The Torrent irrigation system (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via irrig Terminated |
OCX | K103239 |
| Oct 3, 2012 | US Endoscopy Group Inc Endoscopic retrieval device.
The disposable Raptor grasping device in intended to retrieve foreign bodies or resected tissue specimens in endoscopic procedures of the upper and lower gastrointestinal Terminated |
FGO | K962676 |
| Sep 17, 2012 | US Endoscopy Group Inc Infinity sampling device, Cytology Brush, United States Endoscopy Group, Inc., 5976 Heisley Road, Mentor, OH 44060
The Infinity sampling device is a disposable cytology brush used to retrieve cytolog Terminated |
KOG | K103437 |