Eliminator
CONMED Eliminator® 3-stage Pyloric/Colonic PET Balloon Dilator, 18 mm X 4 cm, 54F
9manufacturers in China registered for this device type
21catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (8), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Health Microport Medical Device Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Changzhou Jiuhong Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Jiangsu Changmei Medtech Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 8 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Jiangsu Vedkang Medical Science and Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 20 |
| Hangzhou AGS MedTech Co., Ltd. | Hangzhou | Zhejiang | Repacker / relabeller | 19 |
| Jiangsu Grit Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 13 |
| Jiangsu Power-Endo Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 7 |
| LEO Medical Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 4 |
Record
| Listed by | ConMed Corporation, United States |
|---|---|
| FDA product code | KNQ |
| Device type | Dilator, Esophageal |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5365 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K940965 |
| Record published | 2016-09-24 |
| Record revised | 2024-12-23 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Carton of 5 |
| Sizes | Catheter gauge 18 to 60 Fr; pressure 3400 to 8300 millibar; outer diameter 6 to 20 cm; pressure 50 to 120 psi; length 8 mm; outer diameter 15 to 18 mm; length 8 cm |
| Distribution end date | 2022-06-04 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 000344 | Pressure 4100 millibar | In distribution | |
| 000343 | 2.8 Millimeter | In distribution | |
| 000849 | 2.8 Millimeter | In distribution | |
| 000345 | Pressure 3400 millibar | In distribution | |
| 000858 | 45 French Catheter Outer Diameter | 5 | In distribution |
| 000380 | Pressure 50 psi | In distribution | |
| 000340 | 2.8 Millimeter | In distribution | |
| 000867 | 3.4 Bar Maximum Inflation Pressure | 5 | In distribution |
| 000847 | 4 Centimeter Balloon Length | In distribution | |
| 000736 | 3400/5000 Millibar Pressure 3-Stage Esophageal PET Balloon Dilator Outer Diameter | 5 | In distribution |
| 000846 | 6.2 Bar Maximum Inflation Pressure | In distribution | |
| 000848 | 4 Centimeter Balloon Length | In distribution | |
| 000735 | 2.8 Millimeter | 5 | In distribution |
| 000861 | 3.4 Bar Maximum Inflation Pressure | In distribution | |
| 000845 | 2.8 Millimeter | In distribution | |
| 000342 | Pressure 90 psi | In distribution | |
| 000341 | 2.8 Millimeter | In distribution | |
| 000379 | Length 8 mm | 5 | In distribution |
| 000844 | 6 Millimeter Balloon Outer Diameter | In distribution | |
| 000859 | 54 French Catheter Outer Diameter | 5 | In distribution |
| 000443 | Outer Diameter 12 cm | 5 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Disposable Dilation Balloon | Micro-Tech (Nanjing) Co., Ltd. | 99 |
| Reliant(TM) Multistage Dilatation Balloon Catheter | Micro-Tech (Nanjing) Co., Ltd. | 37 |
| Quantum TTC | Cook Incorporated | 27 |
| Savary Gilliard | Cook Incorporated | 26 |
| SafeGuide® | Diversatek Healthcare Inc | 25 |
| ABC Dilatation Balloon Catheter | Micro-Tech (Nanjing) Co., Ltd. | 21 |
| Flex-Ez Over the Wire Balloon Dilator | Hobbs Medical, Inc. | 19 |
| Flex-Ez Stylet Wire Balloon Dilator | Hobbs Medical, Inc. | 19 |
| Elation 5™ | Merit Medical Systems, Inc. | 18 |
| SafeGuide® Single | Diversatek Healthcare Inc | 16 |
| Conmed CleanGuide | Jiangsu Grit Medical Technology Co., Ltd. | 16 |
| Conmed | ConMed Corporation | 16 |
Showing 12 of 40. All products under Dilator, Esophageal
Recalls Naming This Product
13 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Conmed Endoscopic Technologies, Inc. | 510(k) number | 2007-04-16 | Not classified | Other | Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator. | 68 units. | 2010-07-30 |
| Conmed Endoscopic Technologies, Inc. | 510(k) number | 2007-04-16 | Not classified | Other | Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator. | 414 units. | 2010-07-30 |
| Conmed Endoscopic Technologies, Inc. | 510(k) number | 2007-04-16 | Not classified | Other | Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator. | 384 units (#000343) and 12 units (#000443). | 2010-07-30 |
| Conmed Endoscopic Technologies, Inc. | 510(k) number | 2007-04-16 | Not classified | Other | Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator. | 2,238 units (#000344) and 21 units (#000735). | 2010-07-30 |
| Conmed Endoscopic Technologies, Inc. | 510(k) number | 2007-04-16 | Not classified | Other | Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator. | 3,826 units (#000345) and 41 units (#000736). | 2010-07-30 |
| Conmed Endoscopic Technologies, Inc. | 510(k) number | 2007-04-16 | Not classified | Other | Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator. | 2,964 units (#000380) and 43 units (#000379). | 2010-07-30 |
| Conmed Endoscopic Technologies, Inc. | 510(k) number | 2007-04-16 | Not classified | Other | Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator. | 63 units. | 2010-07-30 |
| Conmed Endoscopic Technologies, Inc. | 510(k) number | 2007-04-16 | Not classified | Other | Complaints received regarding PET Balloon Dilators for a variety of labeling errors, including: incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator. | 172 units. | 2010-07-30 |
| Conmed Endoscopic Technologies, Inc. | 510(k) number | 2007-04-16 | Not classified | Other | Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator. | 452 units. | 2010-07-30 |
| Conmed Endoscopic Technologies, Inc. | 510(k) number | 2007-04-16 | Not classified | Other | Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator. | 152 units (#000847) and 10 units (#000857). | 2010-07-30 |
| Conmed Endoscopic Technologies, Inc. | 510(k) number | 2007-04-16 | Not classified | Other | Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator. | 251 units (#000848) and 13 units (#000858). | 2010-07-30 |
| Conmed Endoscopic Technologies, Inc. | 510(k) number | 2007-04-16 | Not classified | Other | Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator. | 962 units (#000849) and 13 units (#000859). | 2010-07-30 |
| Conmed Endoscopic Technologies, Inc. | 510(k) number | 2007-04-16 | Not classified | Other | Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator. | 239 units (#000861) and 12 units (#000867). | 2010-07-30 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.